The following data is part of a premarket notification filed by Carbomedics, Inc. with the FDA for Biolite Carbon Coated Dental Implant.
| Device ID | K791491 |
| 510k Number | K791491 |
| Device Name: | BIOLITE CARBON COATED DENTAL IMPLANT |
| Classification | Implant, Endosseous, Root-form |
| Applicant | CARBOMEDICS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1979-08-06 |
| Decision Date | 1979-09-04 |