Data / Medical devices / Switzerland / Coltene/Whaledent AG
Coltene/Whaledent AG: FDA-registered device maker in ALTSTAETTEN Sankt Gallen, Switzerland, 27 510(k) clearances
Coltene/Whaledent AG is registered with the FDA (registration 9613375) in ALTSTAETTEN Sankt Gallen, Switzerland. It lists 13 device types. The FDA files 27 510(k) clearances under its listings, the newest dated January 13, 2022. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 9613375
- FEI number
- 3002806620
- Address
- Feldwiesenstrasse 20, ALTSTAETTEN Sankt Gallen, Switzerland, CH-9450
- Owner or operator
- Coltene/Whaledent AG (9089944)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- May 8, 2007
- Registered through
- 2026
- Brand names listed
- A.R.T. Bond, AFFINIS, ALPEN SPEEDSTER, AUTOCLAVABLE, Alpen, Alpen Ceramic Plus ShapeGuard, Alpen Composite Plus ShapeGuard, Alpen Diamond Instruments and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accessories, Retractor, Dental | EIF | 1 | Manufacturer | accessdata.fda.gov |
| Agent, Polishing, Abrasive, Oral Cavity | EJR | 1 | Manufacturer | accessdata.fda.gov |
| Agent, Tooth Bonding, Resin | KLE | 2 | Manufacturer | accessdata.fda.gov |
| Bur, Dental | EJL | 1 | Manufacturer | accessdata.fda.gov |
| Cement, Dental | EMA | 2 | Manufacturer | accessdata.fda.gov |
| Crown And Bridge, Temporary, Resin | EBG | 2 | Manufacturer | accessdata.fda.gov |
| Disk, Abrasive | EHJ | 1 | Manufacturer | accessdata.fda.gov |
| Instrument, Diamond, Dental | DZP | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Material, Impression | ELW | 2 | Manufacturer | accessdata.fda.gov |
| Material, Tooth Shade, Resin | EBF | 2 | Manufacturer | accessdata.fda.gov |
| Point, Abrasive | EHL | 1 | Manufacturer | accessdata.fda.gov |
| Syringe, Restorative And Impression Material | EID | 1 | Manufacturer | accessdata.fda.gov |
| Wheel, Polishing Agent | EJQ | 1 | 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 13, 2022 | K220097 | PRESIDENT The Original | ELW | Substantially Equivalent | Coltène/Whaledent AG | accessdata.fda.gov |
| June 21, 2019 | K190597 | BRILLIANT EverGlow Flow | EBF | Substantially Equivalent | Coltene/Whaledent AG | accessdata.fda.gov |
| August 15, 2018 | K181500 | BRILLIANT Crios | EBF | Substantially Equivalent | Coltene/Whaledent AG | accessdata.fda.gov |
| November 16, 2016 | K160800 | DuoCem | EMA | Substantially Equivalent | Coltene/Whaledent AG | accessdata.fda.gov |
| April 28, 2016 | K152927 | BRILLIANT EVERGLOW | EBF | Substantially Equivalent | Coltene/Whaledent AG | accessdata.fda.gov |
| December 9, 2015 | K152243 | One Coat 7 Universal | KLE | Substantially Equivalent | Coltene/Whaledent AG | accessdata.fda.gov |
| June 23, 2015 | K150218 | Fill-Up! | EBF | Substantially Equivalent | Coltene/Whaledent AG | accessdata.fda.gov |
| January 8, 2013 | K121621 | SOLOCEM | EMA | Substantially Equivalent | Coltene/Whaledent AG | accessdata.fda.gov |
| November 21, 2011 | K112168 | COMPONEER | EBF | Substantially Equivalent | Coltene/Whaledent AG | accessdata.fda.gov |
| February 6, 2009 | K083304 | TEMPOSIL 2 | EMA | Substantially Equivalent | Coltene/Whaledent AG | accessdata.fda.gov |
| November 16, 2007 | K072604 | DUO TEMP | EMA | Substantially Equivalent | Coltene/Whaledent AG | accessdata.fda.gov |
| January 9, 2006 | K052820 | PARAPOST PARACORE AUTOMIX 5ML | EBF | Substantially Equivalent | Coltene/Whaledent AG | accessdata.fda.gov |
| November 9, 2005 | K053040 | PARACEM UNIVERSAL DC | EMA | Substantially Equivalent | Coltene/Whaledent AG | accessdata.fda.gov |
| June 23, 2005 | K051243 | JET BLUE BITE | ELW | Substantially Equivalent | Coltene/Whaledent AG | accessdata.fda.gov |
| February 9, 2005 | K050013 | RETRACTOFOAM | ELW | Substantially Equivalent | Coltene/Whaledent AG | accessdata.fda.gov |
| May 13, 2004 | K041098 | COOL TEMP NATURAL | EBG | Substantially Equivalent | Coltene AG | accessdata.fda.gov |
| January 23, 2004 | K033760 | ONE COAT SE BOND | KLE | Substantially Equivalent | Coltene/Whaledent, Inc. | accessdata.fda.gov |
| August 5, 2003 | K031752 | COLTOSOL F | EMA | Substantially Equivalent | Coltene/Whaledent, Inc. | accessdata.fda.gov |
| December 10, 2001 | K013400 | SYNERGY FLOW | EBF | Substantially Equivalent | Coltene/Whaledent, Inc. | accessdata.fda.gov |
| March 24, 1998 | K974906 | ONE COAT BOND DENTIN/ENAMEL ADHESIVE SYSTEM | KLE | Substantially Equivalent | Coltene/Whaledent, Inc. | accessdata.fda.gov |
| March 9, 1998 | K974465 | SYNERGY | EBF | Substantially Equivalent | Coltene/Whaledent, Inc. | accessdata.fda.gov |
| August 3, 1992 | K922615 | COLTENE A.R.T. BOND | KLE | Substantially Equivalent | Coltene/Whaledent, Inc. | accessdata.fda.gov |
| July 25, 1991 | K912485 | COLTENE PRESIDENT JET LIGHT/REG BODY HYDROPHILIC | ELW | Substantially Equivalent | Coltene/Whaledent, Inc. | accessdata.fda.gov |
| January 29, 1987 | K870047 | COLTENE RAPID | ELW | Substantially Equivalent | Coltene, Inc. | accessdata.fda.gov |
| March 16, 1984 | K840085 | COLTENE BRILLIANT | EBF | Substantially Equivalent | Bauer, Cheng & Associates, Inc. | accessdata.fda.gov |
| July 15, 1981 | K811767 | COLTENE PRESIDENT IMPRESSION MATERIALS | ELW | Substantially Equivalent | Coltene, Inc. | accessdata.fda.gov |
| July 15, 1981 | K811666 | COLTENE COLTEX/COLTOFLAX | ELW | Substantially Equivalent | Coltene, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| July 19, 2019 | 83396 | Class II | Terminated | DIATECH, swiss dental instruments, ROUND END TAPER, 856-016-7-F | A single batch of Diatech Diamond dental burs, 856-016-7-F, Round end taper, contain diamond burs with the same grit size (fine) and shape (round end taper) but different length. | accessdata.fda.gov |
Compare with other makers
- All makers of Material, Tooth Shade, Resin
- All makers of Crown And Bridge, Temporary, Resin
- All makers of Syringe, Restorative And Impression Material
- All makers of Cement, Dental
- All makers of Agent, Polishing, Abrasive, Oral Cavity
- All makers of Agent, Tooth Bonding, Resin
Updated January 13, 2022. 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.