Coltene, Inc.
FDA 510(k) & PMA Approved Devices — 13 products
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Total Devices13
Categories0
Latest FDA decision
| Type | Number | Device Name | Code | Date | Actions |
|---|---|---|---|---|---|
| 510(k) | K902392 | COLTOSOL TEMPORARY ENDODONTIC FILLING MATERIAL | EMA | 1990-08-28 | View |
| 510(k) | K882800 | COLTENE PRESIDENT JET REGULAR BODY | ELW | 1988-09-23 | View |
| 510(k) | K873671 | COLTENE PRESIDENT JET IMPRESSION MATERIALS SYSTEM | EKS | 1987-10-27 | View |
| 510(k) | K870266 | COLTENE BRILLIANT D.I. DIRECT INLAY SYSTEM | EBF | 1987-02-27 | View |
| 510(k) | K870047 | COLTENE RAPID | ELW | 1987-01-29 | View |
| 510(k) | K863998 | COLTENE JET-MIXER | EID | 1986-10-30 | View |
| 510(k) | K850036 | COLTENE PRECISE | ELW | 1985-02-08 | View |
| 510(k) | K840297 | COLTENE ORALLOY MAGICAPS | EJJ | 1984-03-16 | View |
| 510(k) | K811767 | COLTENE PRESIDENT IMPRESSION MATERIALS | ELW | 1981-07-15 | View |
| 510(k) | K811666 | COLTENE COLTEX/COLTOFLAX | ELW | 1981-07-15 | View |
| 510(k) | K811667 | COLTENE PRESSURE SPOT INDICATOR | ELW | 1981-07-15 | View |
| 510(k) | K811363 | COLTENE DRS DENTAL RESTORATIVE SYSTEM | EBF | 1981-06-16 | View |
| 510(k) | K810907 | COLTENE ORALLY | EJJ | 1981-04-23 | View |
No matching devices.
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