The following data is part of a premarket notification filed by Southern Implants, Inc. with the FDA for Endosseous Dental Implant System.
| Device ID | K082651 |
| 510k Number | K082651 |
| Device Name: | ENDOSSEOUS DENTAL IMPLANT SYSTEM |
| Classification | Implant, Endosseous, Root-form |
| Applicant | SOUTHERN IMPLANTS, INC. 5 HOLLAND BLDG 209 Irvine, CA 92618 |
| Contact | Greta M Hols |
| Correspondent | Greta M Hols SOUTHERN IMPLANTS, INC. 5 HOLLAND BLDG 209 Irvine, CA 92618 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-09-12 |
| Decision Date | 2008-12-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06009544027218 | K082651 | 000 |
| D768ABAMCZ30 | K082651 | 000 |
| D768ABAMCZ50 | K082651 | 000 |
| D768ABBBMCZ10 | K082651 | 000 |
| D768ABBBMCZ30 | K082651 | 000 |
| 06009544001638 | K082651 | 000 |
| 06009544001645 | K082651 | 000 |
| 06009544001652 | K082651 | 000 |
| 06009544001669 | K082651 | 000 |
| D768ABAMCZ10 | K082651 | 000 |