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 |