The following data is part of a premarket notification filed by Southern Implants, Inc. with the FDA for Endosseous Dental Implant.
| Device ID | K093562 |
| 510k Number | K093562 |
| Device Name: | ENDOSSEOUS DENTAL IMPLANT |
| Classification | Implant, Endosseous, Root-form |
| Applicant | SOUTHERN IMPLANTS, INC. 5 HOLLAND BLDG 209 Irvine, CA 92618 |
| Contact | Michael Kehoe |
| Correspondent | Michael Kehoe 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 | 2009-11-18 |
| Decision Date | 2010-10-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06009544023791 | K093562 | 000 |
| 06009544022978 | K093562 | 000 |
| 06009544023036 | K093562 | 000 |
| 06009544022787 | K093562 | 000 |
| 06009544022961 | K093562 | 000 |
| 06009544023029 | K093562 | 000 |
| 06009544023043 | K093562 | 000 |
| 06009544023050 | K093562 | 000 |
| 06009544023067 | K093562 | 000 |
| 06009544023715 | K093562 | 000 |
| 06009544023722 | K093562 | 000 |
| 06009544023739 | K093562 | 000 |
| 06009544023746 | K093562 | 000 |
| 06009544023753 | K093562 | 000 |
| 06009544023760 | K093562 | 000 |
| 06009544023777 | K093562 | 000 |
| 06009544023784 | K093562 | 000 |
| 06009544022794 | K093562 | 000 |