The following data is part of a premarket notification filed by Dentos Inc. with the FDA for Absoanchor Microimplant.
| Device ID | K060126 |
| 510k Number | K060126 |
| Device Name: | ABSOANCHOR MICROIMPLANT |
| Classification | Implant, Endosseous, Root-form |
| Applicant | DENTOS INC. 1011 N. UNIVERSITY AVENUE Ann Arbor, MI 48109 |
| Contact | Anna Shafto |
| Correspondent | Anna Shafto DENTOS INC. 1011 N. UNIVERSITY AVENUE Ann Arbor, MI 48109 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-01-18 |
| Decision Date | 2006-05-16 |
| Summary: | summary |