The following data is part of a premarket notification filed by Anthogyr with the FDA for Anthogyr Impulsion Implantology Contra-angle.
Device ID | K093894 |
510k Number | K093894 |
Device Name: | ANTHOGYR IMPULSION IMPLANTOLOGY CONTRA-ANGLE |
Classification | Handpiece, Belt And/or Gear Driven, Dental |
Applicant | ANTHOGYR 2237 AVENUE ANDRE LASQUIN Sallanches, FR 74700 |
Contact | Brayette Sabine |
Correspondent | Brayette Sabine ANTHOGYR 2237 AVENUE ANDRE LASQUIN Sallanches, FR 74700 |
Product Code | EFA |
CFR Regulation Number | 872.4200 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2009-12-18 |
Decision Date | 2010-03-03 |
Summary: | summary |