The following data is part of a premarket notification filed by Altatec Gmbh with the FDA for Camlog Implant System Modified Implants And Abutments.
| Device ID | K083496 |
| 510k Number | K083496 |
| Device Name: | CAMLOG IMPLANT SYSTEM MODIFIED IMPLANTS AND ABUTMENTS |
| Classification | Implant, Endosseous, Root-form |
| Applicant | ALTATEC GMBH 11234 EL CAMINO REAL SUITE 200 San Diego, CA 92130 |
| Contact | Linda K Schulz |
| Correspondent | Linda K Schulz ALTATEC GMBH 11234 EL CAMINO REAL SUITE 200 San Diego, CA 92130 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-11-25 |
| Decision Date | 2009-01-30 |
| Summary: | summary |