The following data is part of a premarket notification filed by Colmed, Ltd. with the FDA for Hollow Basket Titanium Dental Implant.
| Device ID | K801208 |
| 510k Number | K801208 |
| Device Name: | HOLLOW BASKET TITANIUM DENTAL IMPLANT |
| Classification | Implant, Subperiosteal |
| Applicant | COLMED, LTD. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | ELE |
| CFR Regulation Number | 872.3645 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-05-20 |
| Decision Date | 1980-05-28 |