Data / Medical devices / United States / Coltene/Whaledent Inc.
Coltene/Whaledent Inc.: FDA-registered device maker in Cuyahoga Falls, OH, United States, 17 510(k) clearances
Coltene/Whaledent Inc. is registered with the FDA (registration 2416455) in Cuyahoga Falls, OH, United States. It lists 34 device types. The FDA files 17 510(k) clearances under its listings, the newest dated August 16, 2013. 7 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 2416455
- Address
- 235 Ascot Pkwy, Cuyahoga Falls, OH, United States, 44223
- Owner or operator
- Coltene/Whaledent AG (9089944)
- Roles
- Contract manufacturer, Manufacturer, Manufacturer for export, Repackager or relabeler, Specification developer
- First device listed
- March 1, 1996
- Registered through
- 2026
- Brand names listed
- 2 Shape Mini, 2 Shape Mini Procedure Pack, 2Shape, 2Shape Procedure Pack, ALPEN SPEEDSTER, Accutrac Die System Including: Accessories, Kits,, Alpen, Alpen Ceramic Plus ShapeGuard and more
Devices it lists
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 |
|---|---|---|---|---|---|---|
| August 16, 2013 | K123582 | ENDO A CLASS | EKX | Substantially Equivalent | Saeyang Microtech Co., Ltd. | accessdata.fda.gov |
| November 27, 2012 | K121093 | D1 LED CURING LIGHT, SPEC 3, DENTRONIX LED 3000 | EBZ | Substantially Equivalent | Dxm Co., Ltd. | accessdata.fda.gov |
| November 2, 2011 | K111474 | BINGO PRO | LQY | Substantially Equivalent | Forum Engineering Technologies (96) , Ltd. | accessdata.fda.gov |
| October 28, 2011 | K112250 | CHX=CHX PLUS | KJJ | Substantially Equivalent | Inter-Med, Inc. | accessdata.fda.gov |
| April 3, 2009 | K082470 | SODIUM HYPOCHLORITE 3 & 6% SOLUTION AND 6% WITH WETTING AGENTS TO LOWER SURFACE TENSION MARKETED AS CHLOR-XTRA | KJJ | Substantially Equivalent | Inter-Med, Inc. | accessdata.fda.gov |
| October 18, 2007 | K071632 | PERFECT TISSUE CONTOURING SYSTEM II | EKZ | Substantially Equivalent | Coltene/Whaledent, Inc. | accessdata.fda.gov |
| August 21, 2006 | K053555 | ULTRASONIC SCALER, MODELS UDS-N1, UDS-N2. UDS-J, UDS-K, UDS-L | ELC | Substantially Equivalent | Guilin Woodpecker Medical Instrument Co., Ltd. | accessdata.fda.gov |
| August 4, 2005 | K051660 | DENTRONIX DDS 7000 RAPID DRY HEAT STERILIZER STERILIZATION SYSTEM | KMH | Substantially Equivalent | Coltene/Whaledent, Inc. | accessdata.fda.gov |
| March 15, 2004 | K040551 | COLTOLUX LED CURING LIGHT | EBZ | Substantially Equivalent | Coltene/Whaledent, Inc. | accessdata.fda.gov |
| April 14, 2000 | K993545 | TENAX WHITE POST | ELR | Substantially Equivalent | Coltene/Whaledent, Inc. | accessdata.fda.gov |
| March 14, 2000 | K000311 | PARAPOST FIBER WHITE | ELR | Substantially Equivalent | Coltene/Whaledent, 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 |
| January 20, 1999 | K983727 | BIOSONIC ULTRASONIC SCALER SYSTEM | ELC | Substantially Equivalent | Coltene/Whaledent, Inc. | accessdata.fda.gov |
| June 6, 1994 | K934192 | PARAPOST XT SYSTEM | ELR | Substantially Equivalent | Coltene/Whaledent, Inc. | accessdata.fda.gov |
| April 16, 1990 | K900844 | WEDJETS | EIE | Substantially Equivalent | The Hygenic Corp. | accessdata.fda.gov |
| January 10, 1990 | K894092 | DENTAL ENDODONTIC CEMENT (MODIFICATION) | KIF | Substantially Equivalent | The Hygenic Corp. | accessdata.fda.gov |
| June 11, 1987 | K863393 | ENDOCATER | LQY | Substantially Equivalent | The Hygenic 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 |
|---|---|---|---|---|---|---|
| January 20, 2023 | 91601 | Class II | Ongoing | SciCan STATIS SL S10001 Dental Handpieces-Intended for the removal of carious material, reducing hard tooth structure, cavity preparation, finishing tooth preparations, restorations and for polishing teeth. Model Number: | Screw connection between the turbine head and the push button may loosen and fall off during the treatment, and increase the risk of swallowing or inhaling part of the turbines head or the push button | accessdata.fda.gov |
| March 18, 2021 | 87645 | Class II | Ongoing | Dental pins - TMS LINK PLUS Self-Threading Pins - Product Usage: implanted into the teeth or for lab use for dental restoration purposes. The normal procedure requires a hole to be drilled into the tissue of a tooth with | The incorrect dental pins were packaged and subsequently distributed. | accessdata.fda.gov |
| October 20, 2020 | 86694 | Class II | Ongoing | Alpen Clinic 100 Carbide Instruments (R100057C) | The FG 557 bur was incorrectly packaged as the FG 57 bur. The FG 557 burs will remove more material than the FG 57 burs. | accessdata.fda.gov |
| June 3, 2020 | 85794 | Class II | Ongoing | HYGENIC Dental Dam Forceps, Model no. H01262 - Product Usage: The dental dam forceps are intended to be used in conjunction with the rubber dental dam and the dental dam clamps. The forceps are used to place and remove t | Multiple Coltene batches of the product have a pin size larger than acceptable, which may make it difficult for the forceps to fit appropriately with dental dam clamps. | accessdata.fda.gov |
| August 21, 2018 | 81065 | Class II | Terminated | ParaPost Plus 25 Titanium Alloy Spiral Vented and Serrated Posts Catalog Number: P2845B Dental Posts are implanted into teeth for dental restoration purposes. The normal procedure requires a hole to be drilled into the t | ParaPost Plus Titanium Posts contain stainless steel post that are a size 4 | accessdata.fda.gov |
| April 13, 2018 | 79994 | Class II | Terminated | Alpen Carbide 702 Cross Cut Tapered Fissure FG 10 pack (Carbide Burs), Model R100702 a rotary cutting device made from carbon steel or tungsten carbide intended to cut hard structures in the mouth, such as teeth or bone. | The products are labeled with an incorrect product number. | accessdata.fda.gov |
| December 11, 2013 | 67640 | Class II | Terminated | Latex Dental Dams labeled as Non-Latex Dental Dams | Coltne/Whaledent Inc. received a complaint about the dental dams being the incorrect color. During an internal investigation, the firm found that Latex dental dams had been packaged in Non-Latex packaging. | accessdata.fda.gov |
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Updated March 2, 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.