The following data is part of a premarket notification filed by Altatec Gmbh with the FDA for Camlog Abutments Ps.
Device ID | K090347 |
510k Number | K090347 |
Device Name: | CAMLOG ABUTMENTS PS |
Classification | Abutment, Implant, Dental, Endosseous |
Applicant | ALTATEC GMBH 11234 EL CAMINO REAL SUITE 200 San Diego, CA 92130 |
Contact | Linda Schulz |
Correspondent | Linda Schulz ALTATEC GMBH 11234 EL CAMINO REAL SUITE 200 San Diego, CA 92130 |
Product Code | NHA |
CFR Regulation Number | 872.3630 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2009-02-11 |
Decision Date | 2009-06-18 |
Summary: | summary |