The following data is part of a premarket notification filed by Cendres & Metaux Sa with the FDA for Sfi-bar System Complete 2-implant And 4-implant.
Device ID | K083876 |
510k Number | K083876 |
Device Name: | SFI-BAR SYSTEM COMPLETE 2-IMPLANT AND 4-IMPLANT |
Classification | Abutment, Implant, Dental, Endosseous |
Applicant | CENDRES & METAUX SA RUE DE BOUJEAN 122 Biel/bienne, CH 2501 |
Contact | Peter W Fleetwood |
Correspondent | Peter W Fleetwood CENDRES & METAUX SA RUE DE BOUJEAN 122 Biel/bienne, CH 2501 |
Product Code | NHA |
CFR Regulation Number | 872.3630 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2008-12-29 |
Decision Date | 2010-02-26 |