The following data is part of a premarket notification filed by Denar Corp. with the FDA for Denar Dental Implant.
| Device ID | K852802 |
| 510k Number | K852802 |
| Device Name: | DENAR DENTAL IMPLANT |
| Classification | Implant, Endosseous, Root-form |
| Applicant | DENAR CORP. 901 E. CERRITOS AVE. Anaheim, CA 92805 |
| Contact | Ken Krueger |
| Correspondent | Ken Krueger DENAR CORP. 901 E. CERRITOS AVE. Anaheim, CA 92805 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-07-03 |
| Decision Date | 1985-09-23 |