The following data is part of a premarket notification filed by Cendres & Metaux Sa with the FDA for Sfi-bar Implant Adapter Straumann, Sfi-bar Implant Adapter For Neoss Implant.
Device ID | K102382 |
510k Number | K102382 |
Device Name: | SFI-BAR IMPLANT ADAPTER STRAUMANN, SFI-BAR IMPLANT ADAPTER FOR NEOSS IMPLANT |
Classification | Abutment, Implant, Dental, Endosseous |
Applicant | CENDRES & METAUX SA RUE DE BOUJEAN 122 Biel/bienne, CH 2501 |
Contact | Tanja Bongni |
Correspondent | Tanja Bongni CENDRES & METAUX SA RUE DE BOUJEAN 122 Biel/bienne, CH 2501 |
Product Code | NHA |
CFR Regulation Number | 872.3630 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2010-08-23 |
Decision Date | 2010-12-03 |
Summary: | summary |