The following data is part of a premarket notification filed by Stryker Instruments with the FDA for Stryker Precision Dental Implant System.
| Device ID | K921805 |
| 510k Number | K921805 |
| Device Name: | STRYKER PRECISION DENTAL IMPLANT SYSTEM |
| Classification | Implant, Endosseous, Root-form |
| Applicant | STRYKER INSTRUMENTS 420 ALCOTT ST. Kalamazoo, MI 49001 |
| Contact | Chad A Coberly |
| Correspondent | Chad A Coberly STRYKER INSTRUMENTS 420 ALCOTT ST. Kalamazoo, MI 49001 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-04-15 |
| Decision Date | 1994-03-10 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00813110022851 | K921805 | 000 |
| 00813110022844 | K921805 | 000 |
| 00813110022547 | K921805 | 000 |
| 00813110022530 | K921805 | 000 |
| 00813110022516 | K921805 | 000 |
| 00813110022509 | K921805 | 000 |
| 00813110029126 | K921805 | 000 |