Data / Medical devices / United States / Ivoclar Vivadent, Inc.
Ivoclar Vivadent, Inc.: FDA-registered device maker in Amherst, NY, United States, 9 510(k) clearances
Ivoclar Vivadent, Inc. is registered with the FDA (registration 1316092) in Amherst, NY, United States. It lists 11 device types. The FDA files 9 510(k) clearances under its listings, the newest dated May 8, 2018. 9 recall events name it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 1316092
- Address
- 175 Pineview DR., Amherst, NY, United States, 14228
- Owner or operator
- IVOCLAR VIVADENT (8010208)
- Roles
- Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer
- First device listed
- April 16, 1990
- Registered through
- 2027
- Brand names listed
- .585 Fine Gold Solder, .615 Fine Gold Solder, .650 Fine Gold Solder, Academy Gold, Academy Gold XH, AccuDent XD Impression Tray, AccuDent XD Syringe Material, AccuDent XD Tray Adhesive and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Alloy, Amalgam | EJJ | 2 | Manufacturer | accessdata.fda.gov |
| Alloy, Gold-Based Noble Metal | EJT | 2 | Manufacturer | accessdata.fda.gov |
| Alloy, Metal, Base | EJH | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
| Alloy, Other Noble Metal | EJS | 2 | Manufacturer | accessdata.fda.gov |
| Cement, Dental | EMA | 2 | Repackager or relabeler | accessdata.fda.gov |
| Gauge, Depth, Instrument, Dental | EIL | 1 | Repackager or relabeler | accessdata.fda.gov |
| Heat Source For Bleaching Teeth | EEG | 1 | Complaint file establishment | accessdata.fda.gov |
| Material, Impression | ELW | 2 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Syringe, Restorative And Impression Material | EID | 1 | Repackager or relabeler | accessdata.fda.gov |
| Tray, Impression, Preformed | EHY | 1 | Specification developer | accessdata.fda.gov |
| Wax, Dental, Intraoral | EGD | 1 | Complaint file establishment | 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 |
|---|---|---|---|---|---|---|
| May 8, 2018 | K180386 | Meron Plus QM | EMA | Substantially Equivalent | Voco GmbH | accessdata.fda.gov |
| April 3, 2015 | K143575 | Accu-Dent XD Tray, Accu-Dent XD Syringe | ELW | Substantially Equivalent | Ivoclar Vivadent, Inc. | accessdata.fda.gov |
| March 26, 2009 | K083739 | HYDRORISE AND HYDROSYSTEM | ELW | Substantially Equivalent | Zhermack S.P.A. | accessdata.fda.gov |
| March 14, 2008 | K080130 | OCCLUFAST CAD | ELW | Substantially Equivalent | Zhermack S.P.A. | accessdata.fda.gov |
| October 28, 2002 | K022653 | ELITE MONOPHASE | ELW | Substantially Equivalent | Zhermack S.P.A. | accessdata.fda.gov |
| August 1, 1997 | K972239 | ELITE H-D VINYL POLYSILOXANE IMPRESSION MATERIALS .PUTTY SOFT/NORMAL SETTING /PUTTY SOFT/FAST SETTING | ELW | Substantially Equivalent | Zhermack S.P.A. | accessdata.fda.gov |
| July 16, 1997 | K972027 | ELITE H-D HYDROPHILIC VINYL POLYSILOXANE IMPRESSION MATERIALS (LIGHT BODY/NORMAL,LIGHT BODY/FAST SETTING,REGULAR BODY,) | ELW | Substantially Equivalent | Zhermack S.P.A. | accessdata.fda.gov |
| March 11, 1982 | K820389 | A DENTAL AMALGAM ALLOY (UNNAMED | EJJ | Substantially Equivalent | Dentsply Intl. | accessdata.fda.gov |
| August 13, 1980 | K801690 | VALIANT | EJJ | Substantially Equivalent | L.D. Caulk Co. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| December 21, 2023 | 93796 | Class II | Ongoing | Article No. NA6050411, Valiant PhD No. 1 Econo | Affected product may not perform as expected; the amalgam powder may not triturate correctly and the physical properties (i.e. strength, compression, working time, etc.) will be adversely affected. | accessdata.fda.gov |
| August 3, 2017 | 79064 | Class III | Terminated | Heliomolar Refill 20x0.25g 110/A1, Product code 541501AN, Catalog number 541501 | Complaints were filed claiming the material consistency was too soft and too sticky in comparison to its usual consistency, causing unexpected handling for the user during packing and contouring. | accessdata.fda.gov |
| November 9, 2016 | 75620 | Class II | Terminated | Virtual XD Refill Light Body Fast Set Wash Material, 2X50 ml, REF #/Product Code 646461, Rx ONLY -- product Usage: Dental impression material | The firm received complaints claiming the dental material failed to set up. As the dental material ages, the set time may increase. | accessdata.fda.gov |
| July 11, 2016 | 74622 | Class II | Terminated | OptraPol Polishing Discs, Rx ONLY: OptraPol Refill Cup /10: REF/Product ID 634459, OptraPol Refill Small Flame/10: REF/Product ID 634458, OptraPol Assortment: REF/Product ID 634464 --Device Listing # B106952. One step po | After a few seconds of polishing with moderate force, parts of the OptraPol cup are breaking away. OptraPol Small Flame is also affected. Two complaints were filed referring to OptraPol, claiming that the abrasive polishers wear faster than expected. | accessdata.fda.gov |
| May 27, 2016 | 74320 | Class II | Terminated | Zenostar MT Color Impulse blue, Art. no. 681165 Product Usage: For coloring dental porcelain | The primary packaging of these products may show leaks in individual cases. As a consequence, the liquid may escape inadvertently and direct contact with this liquid may lead to skin irritation. | accessdata.fda.gov |
| February 12, 2016 | 73308 | Class II | Terminated | Helioseal Clear Refill 1 x 1.25 g, REF/Product Code/Art. No. 558521AN and Helioseal Clear Assortment 5 x 1.25 g, REF/Product Code/Art. No. 558520AN ---- COMMON/USUAL NAME: Pit & Fissure Sealant | Complaints were received claiming the material failed to polymerize under the curing light. After investigation, it was determined that a wrong photo-initiator was used in the production batch U30755 of Helioseal Clear. This failure can lead to incomplete curing of the sealant, if mono-wave LED curing lights are used. | accessdata.fda.gov |
| July 9, 2015 | 71636 | Class II | Terminated | IPS Empress Universal Glaze Spray 270 mL, Product Code/Model/Catalog Number 609432AN, Rx only. Porcelain glaze spray used in the fabrication of dental restorations | Complaints were received of coarse particles in the glazed surface of IPS e.max Ceram restorations. A basic component of the glass contains a higher number of large grain sizes than usual. | accessdata.fda.gov |
| April 14, 2014 | 67998 | Class II | Terminated | bluephase style Light probe Pin-point 6>2 mm black REF #. The accessory is a pin point light probe, an accessory to a dental curing light Ultraviolet activator for polymerization for use during dental curing. | A stock check revealed broken glass fibers between the connector and the fiber bundle in a large number of these light probes. | accessdata.fda.gov |
| September 23, 2013 | 66359 | Class II | Terminated | ExciTE F DSC Soft touch Single Dose, Dual-curing Regular Ref. 50 dental adhesive for restorations | Ivoclar Vivadent, Inc. is recalling a lot of ExciTE F DSC Dental Adhesive found to produce a blue green discoloration when used in combination with cements. | accessdata.fda.gov |
Compare with other makers
- All makers of Syringe, Restorative And Impression Material
- All makers of Heat Source For Bleaching Teeth
- All makers of Tray, Impression, Preformed
- All makers of Material, Impression
- All makers of Gauge, Depth, Instrument, Dental
- All makers of Alloy, Metal, Base
Updated February 7, 2024. 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.