The following data is part of a premarket notification filed by Calcitek, Inc. with the FDA for Hydroxylapatite Coated Endosseous Dent.
| Device ID | K840750 |
| 510k Number | K840750 |
| Device Name: | HYDROXYLAPATITE COATED ENDOSSEOUS DENT |
| Classification | Implant, Endosseous, Root-form |
| Applicant | CALCITEK, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-02-23 |
| Decision Date | 1984-04-13 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00889024011458 | K840750 | 000 |
| 00889024011441 | K840750 | 000 |