Coltene/Whaledent AG
FDA 510(k) & PMA Approved Devices — 14 products
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Total Devices14
Categories0
Latest FDA decision
| Type | Number | Device Name | Code | Date | Actions |
|---|---|---|---|---|---|
| 510(k) | K191385 | BRILLIANT COMPONEER | EBF | 2019-10-29 | View |
| 510(k) | K190597 | BRILLIANT EverGlow Flow | EBF | 2019-06-21 | View |
| 510(k) | K181500 | BRILLIANT Crios | EBF | 2018-08-15 | View |
| 510(k) | K160800 | DuoCem | EMA | 2016-11-16 | View |
| 510(k) | K152927 | BRILLIANT EVERGLOW | EBF | 2016-04-28 | View |
| 510(k) | K121621 | SOLOCEM | EMA | 2013-01-08 | View |
| 510(k) | K112168 | COMPONEER | EBF | 2011-11-21 | View |
| 510(k) | K083304 | TEMPOSIL 2 | EMA | 2009-02-06 | View |
| 510(k) | K072604 | DUO TEMP | EMA | 2007-11-16 | View |
| 510(k) | K052820 | PARAPOST PARACORE AUTOMIX 5ML | EBF | 2006-01-09 | View |
| 510(k) | K053040 | PARACEM UNIVERSAL DC | EMA | 2005-11-09 | View |
| 510(k) | K051243 | JET BLUE BITE | ELW | 2005-06-23 | View |
| 510(k) | K050426 | TEMPOSIL, MODEL 6720 | EMA | 2005-03-18 | View |
| 510(k) | K050013 | RETRACTOFOAM | ELW | 2005-02-09 | View |
No matching devices.
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