The following data is part of a premarket notification filed by Hager & Meisinger Gmbh with the FDA for Abutment Rp, Abutment Wp, Burn-out Coping, Screws, Titanium Adhesive Base, Alligator Abutment, Solid Abutment, Retentive.
Device ID | K132214 |
510k Number | K132214 |
Device Name: | ABUTMENT RP, ABUTMENT WP, BURN-OUT COPING, SCREWS, TITANIUM ADHESIVE BASE, ALLIGATOR ABUTMENT, SOLID ABUTMENT, RETENTIVE |
Classification | Abutment, Implant, Dental, Endosseous |
Applicant | HAGER & MEISINGER GMBH HANSEMANNSTRASSE 10 Neuss, DE D-41468 |
Contact | Wiebke Stolten |
Correspondent | Wiebke Stolten HAGER & MEISINGER GMBH HANSEMANNSTRASSE 10 Neuss, DE D-41468 |
Product Code | NHA |
CFR Regulation Number | 872.3630 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2013-07-16 |
Decision Date | 2014-07-07 |
Summary: | summary |