Data / Medical devices / United States / Kerr Corporation
Kerr Corporation: FDA-registered device maker in Orange, CA, United States, 86 510(k) clearances
Kerr Corporation is registered with the FDA (registration 2024312) in Orange, CA, United States. It lists 45 device types. The FDA files 86 510(k) clearances under its listings, the newest dated January 12, 2023. 29 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 2024312
- Address
- 1717 W Collins Ave, Orange, CA, United States, 92867
- Owner or operator
- SYBRON DENTAL SPECIALTIES, INC. (9029565)
- Roles
- Complaint file establishment, Contract manufacturer, Manufacturer, Specification developer
- First device listed
- December 15, 1977
- Registered through
- 2026
- Brand names listed
- 37% Phosphoric Acid Etching Gel, Adapt Luciwedge, Alert, Alert Condensable Composite, Apex Connect, Apex Locator, Artiste Nano Composite, Autofit Paper Points and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Activator, Ultraviolet, For Polymerization | EBZ | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Adhesive, Bracket And Tooth Conditioner, Resin | DYH | 2 | Contract manufacturer | accessdata.fda.gov |
| Agent, Polishing, Abrasive, Oral Cavity | EJR | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Agent, Tooth Bonding, Resin | KLE | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Alloy, Amalgam | EJJ | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Amalgamator, Dental, Ac-Powered | EFD | 1 | Complaint file establishment | accessdata.fda.gov |
| Apron, Protective | IWO | 1 | Complaint file establishment | accessdata.fda.gov |
| Battery, Replacement, Rechargeable | MOQ | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Capsule, Dental, Amalgam | DZS | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Cement, Dental | EMA | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Cleanser, Root Canal | KJJ | U | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Controller, Foot, Handpiece And Cord | EBW | 1 | Complaint file establishment | accessdata.fda.gov |
| Cord, Retraction | MVL | U | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Crown And Bridge, Temporary, Resin | EBG | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Dental Cement W/Out Zinc-Oxide Eugenol As An Ulcer Covering For Pain Relief | MZW | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Drill, Dental, Intraoral | DZA | 1 | Complaint file establishment | accessdata.fda.gov |
| Explorer, Operative | EKB | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Gauge, Depth, Instrument, Dental | EIL | 1 | Complaint file establishment | accessdata.fda.gov |
| Handpiece, Air-Powered, Root Canal Irrigation | NYL | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Handpiece, Belt And/Or Gear Driven, Dental | EFA | 1 | Complaint file establishment | accessdata.fda.gov |
| Handpiece, Direct Drive, Ac-Powered | EKX | 1 | Complaint file establishment | accessdata.fda.gov |
| Instrument, Filling, Plastic, Dental | EIY | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Instruments, Dental Hand | DZN | 1 | Complaint file establishment, Contract manufacturer, Specification developer | accessdata.fda.gov |
| Liner, Cavity, Calcium Hydroxide | EJK | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Locator, Root Apex | LQY | U | Complaint file establishment | accessdata.fda.gov |
| Material, Impression | ELW | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Material, Tooth Shade, Resin | EBF | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Mercury | ELY | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Paper, Articulation | EFH | 1 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Pliers, Operative | EJY | 1 | Complaint file establishment | accessdata.fda.gov |
| Point, Paper, Endodontic | EKN | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Preparer, Root Canal Endodontic | EKQ | 1 | Complaint file establishment | accessdata.fda.gov |
| Protector, Dental | BRW | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Reamer, Pulp Canal, Endodontic | EKP | 1 | Manufacturer | accessdata.fda.gov |
| Resin, Denture, Relining, Repairing, Rebasing | EBI | 2 | Complaint file establishment | accessdata.fda.gov |
| Resin, Root Canal Filling | KIF | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Retractor, All Types | EIG | 1 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Scaler, Ultrasonic | ELC | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Sealant, Pit And Fissure, And Conditioner | EBC | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | KCT | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Tester, Pulp | EAT | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Tray, Fluoride, Disposable | KMT | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Tray, Surgical, Instrument | FSM | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Wrap, Sterilization | FRG | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Zinc Oxide Eugenol | EMB | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| January 12, 2023 | K222830 | Rainbow 360 | KLE | Substantially Equivalent | Kerr Corporation | accessdata.fda.gov |
| September 21, 2022 | K210475 | EQ-M | EKX | Substantially Equivalent | Meta Systems Co., Ltd. | accessdata.fda.gov |
| August 31, 2022 | K221255 | SimpliShade Bulk Fill, SimpliShade Bulk Fill Flow | EBF | Substantially Equivalent | Kerr Corporation | accessdata.fda.gov |
| October 20, 2021 | K210789 | EQ-PEX | LQY | Substantially Equivalent | Meta Systems Co., Ltd. | accessdata.fda.gov |
| June 7, 2019 | K190503 | CeraSeal | KIF | Substantially Equivalent | Meta Biomed Co., Ltd. | accessdata.fda.gov |
| November 7, 2018 | K182162 | OptiBond eXTRa Universal | KLE | Substantially Equivalent | Kerr Corporation | accessdata.fda.gov |
| July 18, 2017 | K163064 | Demi Ultra | EBZ | Substantially Equivalent | Kerr Corporation | accessdata.fda.gov |
| April 21, 2017 | K162063 | Steri-Cassette and Steri-Cage Sterilization Packaging System | KCT | Substantially Equivalent | Sybron Dental Specialties | accessdata.fda.gov |
| March 17, 2017 | K163239 | SMARTmatic | EFA | Substantially Equivalent | Kaltenbach & Voigt GmbH | accessdata.fda.gov |
| February 21, 2017 | K163317 | ELECTROmatic | EBW | Substantially Equivalent | Kaltenbach & Voigt Gmgh | accessdata.fda.gov |
| February 3, 2017 | K162536 | GingiKnit+, GingiBraid+, GingiBraid+ Shortcut, and UniBraid+ impregnated Aluminum Potassium Sulfate Retraction Cord | MVL | Substantially Equivalent | Kerr Corporation | accessdata.fda.gov |
| January 13, 2017 | K162164 | GingiKnit+, GingiBraid+, and Shortcut with GingiBraid+ Non-Impregnated Retraction Cord | MVL | Substantially Equivalent | Kerr Corporation | accessdata.fda.gov |
| November 7, 2016 | K162257 | P1145 Dental Restorative | EBF | Substantially Equivalent | Kerr Corporation | accessdata.fda.gov |
| July 27, 2016 | K153067 | Tubli-Seal, Tubli-Seal EWT,Tubli-Seal Xpress, Tubli-Seal EWT Xpress | KIF | Substantially Equivalent | Sybron Dental Specialties | accessdata.fda.gov |
| June 30, 2016 | K160441 | Identic and KromaFaze Alginate Dental Impression Materials | ELW | Substantially Equivalent | Kerr Corporation | accessdata.fda.gov |
| May 6, 2016 | K152956 | Pulp Canal Sealer, Pulp Canal Sealer EWT | KIF | Substantially Equivalent | Sybron Dental Specialties | accessdata.fda.gov |
| April 14, 2016 | K152959 | Sealapex tubes, Sealapex bulk package, Sealapex Xpress dual-barrel syringes | KIF | Substantially Equivalent | Sybron Dental Specialties | accessdata.fda.gov |
| September 10, 2015 | K151526 | Zone, ZoneFree, Zone A1 | EMA | Substantially Equivalent | Sybron Dental Specialties | accessdata.fda.gov |
| February 5, 2015 | K143209 | SonicFill 2 | EBF | Substantially Equivalent | Sybron Dental Specialties | accessdata.fda.gov |
| July 2, 2014 | K140685 | ENDO VAC APICAL NEGATIVE PRESSURE IRIGATION SYSTEM | NYL | Substantially Equivalent | Sybron Endo | accessdata.fda.gov |
| April 26, 2012 | K112153 | IROOT 100 MINI | LQY | Substantially Equivalent | S-Denti Co., Ltd. | accessdata.fda.gov |
| July 22, 2011 | K111348 | RE / STASIS (TM) GINGIVAL RETRACTION PASTE | MVL | Substantially Equivalent | Centrix, Inc. | accessdata.fda.gov |
| June 14, 2011 | K111078 | AEU-26L ELCTRONIC ENDODONTIC SYSTEM | EKX | Substantially Equivalent | Aseptico, Inc. | accessdata.fda.gov |
| April 5, 2011 | K110378 | IMPRESSION COMPOUND | ELW | Substantially Equivalent | Spofadental | accessdata.fda.gov |
| January 20, 2011 | K103351 | DMC COMPOSITE 2 | EBF | Substantially Equivalent | Kerr Corporation | accessdata.fda.gov |
| July 30, 2010 | K101423 | OPTIBOND XTR | KLE | Substantially Equivalent | Kerr Corporation | accessdata.fda.gov |
| October 30, 2009 | K091512 | BUILD-IT LIGHT CURE | EBF | Substantially Equivalent | Pentron Clinical Technologies | accessdata.fda.gov |
| October 14, 2009 | K091091 | SONICFILL 2010 | EBF | Substantially Equivalent | Sybron Dental Specialties, Inc. | accessdata.fda.gov |
| October 7, 2009 | K091613 | TAKE 1 | ELW | Substantially Equivalent | Kerr Corp. | accessdata.fda.gov |
| April 3, 2009 | K090292 | PREMISE MODIFIED | EBF | Substantially Equivalent | Kerr Corp. | accessdata.fda.gov |
| December 11, 2008 | K082671 | HERCULITE ULTRA | EBF | Substantially Equivalent | Sybron Dental Specialties | accessdata.fda.gov |
| January 29, 2008 | K073209 | MAXCEM 2 | MZW | Substantially Equivalent | Kerr Corporation | accessdata.fda.gov |
| November 21, 2007 | K072480 | GENERATION 8 SE ADHESIVE | KLE | Substantially Equivalent | Pentron Clinical Technologies | accessdata.fda.gov |
| October 26, 2007 | K072545 | ARTISTE SE FLOWABLE COMPOSITE, MODEL N280 | EBF | Substantially Equivalent | Pentron Clinical Technologies | accessdata.fda.gov |
| July 26, 2007 | K071251 | DEMI | EBZ | Substantially Equivalent | Kerr Corporation | accessdata.fda.gov |
| October 19, 2006 | K062519 | NEXUS 3 | EMA | Substantially Equivalent | Kerr Corporation | accessdata.fda.gov |
| April 28, 2006 | K060472 | PREMISE FLOWABLE | EBF | Substantially Equivalent | Kerr Corporation | accessdata.fda.gov |
| March 28, 2006 | K060469 | OPTIBOND ALL-IN-ONE | KLE | Substantially Equivalent | Sybron Dental Specialties, Inc. | accessdata.fda.gov |
| November 13, 2003 | K032921 | PREMISE | EBF | Substantially Equivalent | Sybron Dental Specialties, Inc. | accessdata.fda.gov |
| July 2, 2003 | K031444 | OPTIBOND FL | KLE | Substantially Equivalent | Kerr Dental Materials Center | accessdata.fda.gov |
| March 5, 2003 | K024198 | SMEARCLEAR | KJJ | Substantially Equivalent | Sybron Dental Specialties, Inc. | accessdata.fda.gov |
| July 5, 2002 | K021253 | ULTRASONIC TIPS WITH DIAMOND COATING | ELC | Substantially Equivalent | Sybron Endo/Analytic | accessdata.fda.gov |
| June 19, 2002 | K021298 | ELEMENTS DIAGNOSTIC UNIT | EAT | Substantially Equivalent | Sybron Endo/Analytic | accessdata.fda.gov |
| April 22, 2002 | K020555 | SONATA MICRO HYBRID COMPOSITE | EBF | Substantially Equivalent | Pentron Laboratory Technologies | accessdata.fda.gov |
| February 22, 2002 | K020092 | TEMPHASE | EBG | Substantially Equivalent | Kerr Dental Materials Center | accessdata.fda.gov |
| February 14, 2002 | K013542 | DENTIN CONDITIONING AND ADHESIVE SYSTEM (BOND-1) | KLE | Substantially Equivalent | Jeneric/Pentron, Inc. | accessdata.fda.gov |
| January 18, 2002 | K013510 | POINT 4 MODIFIED | EBF | Substantially Equivalent | Sybron Dental Specialties, Inc. | accessdata.fda.gov |
| January 16, 2002 | K013647 | REVOLUTION FORMULA 2 | EBF | Substantially Equivalent | Sybron Dental Specialties, Inc. | accessdata.fda.gov |
| January 16, 2002 | K013609 | NEXUS 2 CLEAR | EMA | Substantially Equivalent | Sybron Dental Specialties, Inc. | accessdata.fda.gov |
| January 9, 2002 | K013529 | POINT 4 TRANSLUCENT MODIFIED | EBF | Substantially Equivalent | Sybron Dental Specialties, Inc. | accessdata.fda.gov |
| October 29, 2001 | K013375 | BELLEGLASS HP OPAQUE 2 | EBF | Substantially Equivalent | Kerr Dental Materials Center | accessdata.fda.gov |
| October 25, 2001 | K012717 | LIFE 2 | EJK | Substantially Equivalent | Sybron Dental Specialties, Inc. | accessdata.fda.gov |
| October 3, 2001 | K013009 | BELLEGLASS HP DC OPACEOUS DENTIN LCTE 2 | EBF | Substantially Equivalent | Sybron Dental Specialties, Inc. | accessdata.fda.gov |
| October 1, 2001 | K013007 | BELLEGLASS HP ENAMEL 2 | EBF | Substantially Equivalent | Sybron Dental Specialties, Inc. | accessdata.fda.gov |
| August 14, 2001 | K011798 | CORERESTORE 2 | EBF | Substantially Equivalent | Sybron Dental Specialties, Inc. | accessdata.fda.gov |
| February 15, 2001 | K003650 | PERMLASTIC 3 | ELW | Substantially Equivalent | Sybron Dental Specialties, Inc. | accessdata.fda.gov |
| August 28, 2000 | K001899 | IMPROVED TRY-IN GEL | EBF | Substantially Equivalent | Sybron Dental Specialties, Inc. | accessdata.fda.gov |
| July 5, 2000 | K001218 | CORRECT PLUS | ELW | Substantially Equivalent | Jeneric/Pentron, Inc. | accessdata.fda.gov |
| April 28, 2000 | K000954 | KERR GEL ETCHANT | KLE | Substantially Equivalent | Sybron Dental Specialties, Inc. | accessdata.fda.gov |
| April 28, 2000 | K000357 | EZ CONNECT RESIN | EBF | Substantially Equivalent | Kerr Dental Materials Center | accessdata.fda.gov |
| April 14, 2000 | K000346 | EZ CONNECT | EBG | Substantially Equivalent | Kerr Dental Materials Center | accessdata.fda.gov |
| March 24, 2000 | K000436 | BELLEGLASS HP TRANSLUCENT DENTIN | EBF | Substantially Equivalent | Sybron Dental Specialties, Inc. | accessdata.fda.gov |
| October 14, 1999 | K992484 | RCNG: ROOT CANAL NEGOTIATING GEL; MODEL RCNG | KJJ | Substantially Equivalent | Jordco, Inc. | accessdata.fda.gov |
| July 9, 1999 | K991808 | OPTIBOND SOLO PLUS 2 | KLE | Substantially Equivalent | Sybron Dental Specialties, Inc. | accessdata.fda.gov |
| March 24, 1999 | K990682 | PROPHY-MATE MOTOR HANDPIECE, MODELS PROPHY-MATE (2000 RPM MAX), ENDO-MATE (600RPM MAX.) | EKX | Substantially Equivalent | Nsk Nakanishi, Inc. | accessdata.fda.gov |
| February 25, 1999 | K990225 | ENDO ANALYZER, MODEL 8005, MODIFIED | EAT | Substantially Equivalent | Sybron Dental Specialties, Inc. | accessdata.fda.gov |
| February 18, 1999 | K984483 | A-SOFT RELINER | EBI | Substantially Equivalent | S & C Polymer GmbH | accessdata.fda.gov |
| December 17, 1997 | K974131 | ALERT | EBF | Substantially Equivalent | Jeneric/Pentron, Inc. | accessdata.fda.gov |
| September 12, 1997 | K973388 | DENTIN CONDITIONING AND ADHESIVE (BOND 1) | KLE | Substantially Equivalent | Jeneric/Pentron, Inc. | accessdata.fda.gov |
| April 7, 1997 | K970715 | SYSTEM B HEAT SOURCE | EAT | Substantially Equivalent | Sybron Dental Specialties, Inc. | accessdata.fda.gov |
| December 2, 1996 | K963862 | TOUCH N' HEAT | EAT | Substantially Equivalent | Sybron Dental Specialties, Inc. | accessdata.fda.gov |
| May 8, 1996 | K961284 | KOLOR + | EBF | Substantially Equivalent | Sybron Dental Specialties, Inc. | accessdata.fda.gov |
| January 4, 1996 | K954827 | SEALITE FL | EBC | Substantially Equivalent | Sybron Dental Specialties, Inc. | accessdata.fda.gov |
| January 2, 1996 | K955331 | BELLEGLASHP | EBG | Substantially Equivalent | Sybron Dental Specialties, Inc. | accessdata.fda.gov |
| September 7, 1995 | K953859 | BOND-IT DUAL CURE ACTIVATOR | KLE | Substantially Equivalent | Jeneric/Pentron, Inc. | accessdata.fda.gov |
| August 28, 1995 | K952662 | COMP=FLOW | EBF | Substantially Equivalent | Jeneric/Pentron, Inc. | accessdata.fda.gov |
| June 6, 1995 | K951663 | TYTIN R | EJJ | Substantially Equivalent | Kerr Corporation (Danbury) | accessdata.fda.gov |
| December 29, 1994 | K945539 | OPTIGUARD | EBF | Substantially Equivalent | Sybron Dental Specialties, Inc. | accessdata.fda.gov |
| November 17, 1994 | K943642 | HERCULITE XR & XRV | EBF | Substantially Equivalent | Sybron Dental Specialties, Inc. | accessdata.fda.gov |
| March 15, 1994 | K936222 | DENTIN CONDITIONING AND ADHESIVE SYSTEM | KLE | Substantially Equivalent | Jeneric/Pentron, Inc. | accessdata.fda.gov |
| March 11, 1994 | K935535 | TYTIN | EJJ | Substantially Equivalent | Kerr Corporation (Danbury) | accessdata.fda.gov |
| February 14, 1994 | K934714 | ENDODONTIC PULP CANAL SPREADER | ELC | Substantially Equivalent | Excellence IN Endodontics, Inc. | accessdata.fda.gov |
| April 28, 1992 | K914178 | CORRECTED-V.P.S. | ELW | Substantially Equivalent | Jeneric/Pentron, Inc. | accessdata.fda.gov |
| January 10, 1990 | K894437 | PEEL-VUE AUTOCLAVE/CHEMICALVE POUCH | FRG | Substantially Equivalent | Clive Craig Co. | accessdata.fda.gov |
| February 11, 1988 | K874189 | DUAL-CURE RADIOPAQUE | EBF | Substantially Equivalent | Pentron Corp. | accessdata.fda.gov |
| February 24, 1982 | K820181 | SYBRON/KERR CONTOUR | EJJ | Substantially Equivalent | Sybron Corp. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| February 25, 2020 | 85284 | Class II | Terminated | Nexus Universal with OptiBond Universal, Universal Adhesive Resin Cement, Trial Kit, Ref # 36990 - Product Usage: The intended use of this device is to be used for the cementation of indirect restorations including venee | An issue within production process used to package trial kits let to the inclusion of the incorrect bonding agent for the kit. Use of the incorrect bonding agent may lead to increased risk of bond failures. | accessdata.fda.gov |
| July 13, 2018 | 82553 | Class II | Terminated | Regimen 28 Day - Glutaraldehyde Sterilizing and Disinfecting Solution | Immersion time stated on the bottle is 45 minutes while the product instructions say 90 minutes. | accessdata.fda.gov |
| February 11, 2015 | 70551 | Class II | Terminated | Outer cardboard box labeling: Pinnacle Cure Sleeve, Curing Light Tip Sleeves. Kerr Total Care. Part Number: 4513C or 4513-1 Single Patient Use Fits 13mm Tips. Pack of 400. Metrex Research, Manufacturer. Inner individual | Cases of Cure Sleeve labeled with part number 4513, which fits 13mm tips, have inner boxes labeled with part number 4500 which fit 7mm and 8mm tips. There is a low risk associated with the use of the product as the sleeve may tear causing a potential for cross contamination. | accessdata.fda.gov |
| September 13, 2013 | 66276 | Class II | Terminated | NX3 Try-In Gel. The product is used as a tooth shade resin material. | Kerr Corporation is voluntarily recalling one lot of NX3 Try-In Gel, because some of the NX3 Try-In Gel syringes in the affected lot contain a different product material. The material in the affected syringe does not match the shade of the cement as it is labeled. | accessdata.fda.gov |
| June 6, 2013 | 66110 | Class II | Terminated | AOA Mini RPE Screw Assembly, a component of Herbst, MARA and Fixed Metal devices. Product Usage: AOA Mini RPE Screw Assembly is a component of Herbst, MARA and Fixed Metal devices; removable functional appliances that ar | The firm initiated the recall of AOA Mini RPE Screw Assembly, because it may be missing a complete weld joining one side of the arm with the screw body. Herbst, MARA and Fixed Metal devices may be affected, because they contain an AOA Mini RPE Screw Assembly. | accessdata.fda.gov |
| February 22, 2013 | 64559 | Class II | Terminated | Kerr Maxcem Elite, self-etch/self-adhesive resin cement; Intro Kit Part No. 34417; DMC 0446 Rev 0. Used for cementation of all indirect restorations. | Kerr Corporation is initiating this recall because raw material used to produce the Maxcem Elite is causing the material to prematurely polymerize in the syringe. The product could be difficult to extrude or demonstrate a shorter work-time as the material may prematurely set prior to placing restorations on the tooth or core build-up. As a result, the restor | accessdata.fda.gov |
| October 25, 2012 | 63557 | Class II | Terminated | BioPlant, a dental bone grafting material. BioPlant has been assigned the product code LYC (Bone Grafting Material, Synthetic) by the FDA and is classified as a Class II Medical Device. BioPlant is a Class II Medical Dev | The firm initiated the recall becaue disturbing the BioPlant product soon after it is placed may halt or delay the ossification process. | accessdata.fda.gov |
| July 8, 2011 | 60242 | Not yet classified | Terminated | Breeze Self-Adhesive Resin Cement, Part Number: N97A, Product Usage: The intended use of this device is for cementation of porcelain, resin, and metalbased inlays, onlays, crowns, bridges and posts. The material is not r | Pentron is voluntarily recalling the Breeze Self Adhesive Resin Cement because it was discovered that there may be a curing problem that may cause cemented crowns to fall off after use of the product. | accessdata.fda.gov |
| March 31, 2011 | 60114 | Not yet classified | Terminated | 37% Etching Gel-1ml syringe, part # T06 The intended use of these devices is to etch tooth dentin/enamel in order to prepare the tooth surface prior to the application of a bonding agent. | Pentron Clinical is voluntarily recalling all lots of products labeled as 37% Phosphoric Acid Etching Gel produced since April 2007 because the product continues to extrude out of the syringe even after pressure is no longer applied, and it contains a higher percentage of phosphoric acid than that indicated on the label. | accessdata.fda.gov |
| March 17, 2011 | 60359 | Not yet classified | Terminated | Dental cement under the brand name Cement-It and Natural Elegance (private label of Cement-It). The intended use of this device is to affix dental devices such as crowns or bridges onto the tooth. Cement-It and Natural E | The firm initiated a recall because the product sets faster than specified in the "Directions for Use" and in release specifications. | accessdata.fda.gov |
| March 3, 2011 | 61270 | Not yet classified | Terminated | Brand Name: TempSpan CMT Temporary Cement, a temporary cement. Part Number: N69CA. The intended use of this device is to affix a temporary dental devices such as crowns or bridges to a tooth. | The recall was initiated because Pentron Clinical has confirmed that the TempSpan Temporary Cement may have black plastic material on the surface of the paste, and it may set faster than specified. | accessdata.fda.gov |
| March 3, 2011 | 60693 | Not yet classified | Terminated | Artiste Nano-Hybrid Affected Product. Syringe Part No. Value Pack Part. No Shade N28A N28VA A1 N28B N28VB A2 N28C N28VC A3 N28D N28VD A3.5 N28E N28VE A4 N28F N28VF B1 N28G N28VG B2 N28J N28VJ C1 N28K N28VK C2 N28L N28VL | The recall was initiated because Pentron Clinical has confirmed that the Flow Tec Nano-Hybrid Flowable Composite material has been found to be difficult to extrude. | accessdata.fda.gov |
| March 3, 2011 | 60551 | Not yet classified | Terminated | Artiste Maverick Tint, Part Number: N36TB, Lot/Serial Numbers: 3416180, Product Description and Intended Use: The intended use of this device is for internal color characterization and includes 3 opaques for blocking out | The resin material separates when the product is extruded from the syringe. Although there are no safety issues related with this situation, please refrain from using the affected product. | accessdata.fda.gov |
| February 3, 2011 | 60685 | Not yet classified | Terminated | Brand name: Maxcem Elite, Product: a dental cement, Part Number: 34418. The intended use of this device is for cementation of all indirect restorations including ceramic, resin and metal-based inlays, onlays, crowns, bri | The recall was initiated because Kerr Corporation has confirmed that the use of the affected lot of Maxcem Elite may not provide users with a minimum of 2 minutes of worktime thereby causing the product to prematurely set by 15 seconds. | accessdata.fda.gov |
| December 2, 2010 | 61235 | Not yet classified | Terminated | Breeze Self-Adhesive Resin Cement, part number: N97F. The intended use is for cementation of porcelain, resin, and metal-based inlays, onlays, crowns, bridges, and posts. | The recall was initiated because Pentron Clinical has confirmed that the Breeze Self-Adhesive Resin Cement exhibits faster than expected gel and set times. If the work time is exceeded when using this material, it could possibly result in inadequate bond strength. | accessdata.fda.gov |
| November 4, 2010 | 59959 | Not yet classified | Terminated | Correct VPS Vinyl Polysilocane Impression Material, Product Number Q01B. The intended use of this device is as a dental impression material. | Pentron Clinical is voluntarily recalling the following lot of mislabeled Correct VPS Medium Body Tubes. It was discovered that the individual tubes inside the Correct VPS Medium Body Tube boxes are missing the lot/expiration date sticker. | accessdata.fda.gov |
| October 22, 2010 | 59936 | Not yet classified | Terminated | Artiste Flowable Value Pack Part Number N28VA, Syringe Lot Number 165741 The intended use of the device is as a light cured, low viscosity, hybrid composite material which is compatible with a variety of bonding agents a | The recall was initiated because Pentron Clinical has confirmed the Flow Tec Nano Hybrid Flowable Composite material has been found to be difficult to extrude. | accessdata.fda.gov |
| August 19, 2010 | 61239 | Not yet classified | Terminated | Brand Name: Fusio Liquid Dentin, part number N21SB, N21SC. Product Usage: The intended use of this device is as a self-etch, self-adhesive flowable resin composite indicated for light-cured dental restorations. Applicati | A recall was initiated because Pentron Clinical has confirmed that the Fusio Liquid Dentin is not as flowable as ideally expected. | accessdata.fda.gov |
| May 27, 2010 | 61265 | Not yet classified | Terminated | Brand name: Bond-1 Primer/Adhesive, a resin tooth bonding agent. Item # Item Description N01I Bond-1 Prim/Adhesive Kit N01IAA Bond-1 Primer/Adhesive 4ml N01IAB Bond-1 Primer/Adhesive 6ml N04 Lute-it w/ Bond-1 kit N04B Lu | The recall was initiated because Pentron Clinical has confirmed that various lots of Bond-1 Primer/Adhesive have been found to have gelled and therefore becomes unusable. | accessdata.fda.gov |
| October 27, 2009 | 53812 | Not yet classified | Terminated | Elements Gutta Percha and Elements RealSeal Cartridges; Part Number: | The recall was initiated because during the manufacturing process of the affected units, the molding process resulted in lock nuts that did not have the level of acceptability required, and therefore, may not withstand the pressures exhibited by the Elements Obturation Unit with which the cartridges are used. More Specifically, there exists a possibility tha | accessdata.fda.gov |
| September 9, 2009 | 53296 | Not yet classified | Terminated | Kerr TempBond Clear, Part # 33351, 1717 West Collins Avenue, Orange, CA 92867. Intended for use in a dual-cured, temporary resin-based cement designed to be used in conjunction with temporary restoration such as crowns, | The recall was initiated because the catalyst portion of the syringe may have polymerized, therefore making the product unusable. | accessdata.fda.gov |
| August 24, 2009 | 54490 | Not yet classified | Terminated | Bond-1 Primer/Adhesive. The intended use of this device is adhesion to dentin of various polymeric filling materials (composites) used with other conditioners or combination of conditioners for bonding of composite to me | Some of the material has been found to be gelled and therefore becomes unusable. | accessdata.fda.gov |
| February 23, 2009 | 53480 | Not yet classified | Terminated | Sealapex Express (Part Number: 33639), root canal filling material. Manufactured by SybronEndo, Glendora, CA. Intended as a root canal filling material that is used in conjunction with gutta percha or silver endodontic p | Sybron Dental Specialties is initiating a recall on the Sealapex Xpress due to the presence of crystals in the catalyst. This crystallization may affect proper canal filling by preventing Gutta Percha Points from reaching the bottom of the root canal which may lead to an inadequate seal. | accessdata.fda.gov |
| February 23, 2009 | 53431 | Not yet classified | Terminated | Herculite Ultra (Part Number 34333), dental composite resorative material. Manufactured by Kerr Corporation, Orange, CA. | Sybron Dental Specialties is initiating a field correction on the Herculite Ultra, a dental composite restorative material, due to a mistake in the directions for use located in the Herculite technique card. | accessdata.fda.gov |
| November 14, 2008 | 50763 | Not yet classified | Terminated | Neos Vanadium Excavator Part Number 591/0 | The tips of the Neos Vanadium Excavators may prematurely release from the handle during use, and if so, the tip may be accidentally swallowed. | accessdata.fda.gov |
| September 5, 2008 | 49506 | Not yet classified | Terminated | PREMISE, PART NO. 32650, 10 PACK UNIDOSE PREMISE A1, dental composite | Material stiff: Material in several lots of Premise Unidose appears to stiffen and become difficult to extrude over time. | accessdata.fda.gov |
| August 29, 2006 | 36200 | Not yet classified | Terminated | OptiBond Solo Plus Self-Etch Adhesive System, Part Number 31966 | Mis-pack/mis-label: The OptiBond Self Etch Primer and OptiBond Solo Plus Adhesive in the chambers were mis-packaged/mis-labeled in reverse order. Application of these products in reverse order may result in compromised bond strength. | accessdata.fda.gov |
| August 14, 2006 | 36222 | Not yet classified | Terminated | TempBond Clear Syringes (base and catalyst kit), a temporary dental cement, Part Number 28637 | Low Bonding performance: The affected lots of product may not activate properly, which may cause lower than expected bonding performance (due to a low level of chemical cure initiator in the lots manufactured) | accessdata.fda.gov |
| March 3, 2006 | 34769 | Not yet classified | Terminated | Tooth bonding resin. Optibond Solo Plus, Part Number 31513, Lot Numbers 427936, 428569, & 428290 | The affected lot of product may not activate properly throughout the full intended shelf life and may result in lower than expected bonding performance. | accessdata.fda.gov |
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Updated January 12, 2023. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.