The following data is part of a premarket notification filed by Cendres & Metaux Sa with the FDA for Sfi-bar (r) Implant Adapter Spi (r) Element Pf 0 4.0 / H 3.0 / H 4.0 / H 5.0 / H 6.0, Sfi-bar (r) Implant Adapter Stra...
Device ID | K111390 |
510k Number | K111390 |
Device Name: | SFI-BAR (R) IMPLANT ADAPTER SPI (R) ELEMENT PF 0 4.0 / H 3.0 / H 4.0 / H 5.0 / H 6.0, SFI-BAR (R) IMPLANT ADAPTER STRA.. |
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 | 2011-05-18 |
Decision Date | 2011-09-12 |
Summary: | summary |