Device Classification Name |
Abutment, Implant, Dental, Endosseous
|
510(k) Number |
K132214 |
Device Name |
ABUTMENT RP, ABUTMENT WP, BURN-OUT COPING, SCREWS, TITANIUM ADHESIVE BASE, ALLIGATOR ABUTMENT, SOLID ABUTMENT, RETENTIVE |
Applicant |
HAGER & MEISINGER GMBH |
HANSEMANNSTRASSE 10 |
NEUSS,
DE
D-41468
|
|
Applicant Contact |
WIEBKE STOLTEN |
Correspondent |
HAGER & MEISINGER GMBH |
HANSEMANNSTRASSE 10 |
NEUSS,
DE
D-41468
|
|
Correspondent Contact |
WIEBKE STOLTEN |
Regulation Number | 872.3630
|
Classification Product Code |
|
Date Received | 07/16/2013 |
Decision Date | 07/07/2014 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|