Device Classification Name |
Abutment, Implant, Dental, Endosseous
|
510(k) Number |
K151324 |
FOIA Releasable 510(k) |
K151324
|
Device Name |
Straumann Variobase for CEREC |
Applicant |
STRAUMANN USA, LLC |
60 MINUTEMAN ROAD |
ANDOVER,
MA
01810
|
|
Applicant Contact |
Christopher Klaczyk |
Correspondent |
Heyer Regulatory Solutions LLC |
125 Cherry Lane |
Amherst,
MA
01002
|
|
Correspondent Contact |
Sheila Hemeon-Heyer |
Regulation Number | 872.3630
|
Classification Product Code |
|
Date Received | 05/18/2015 |
Decision Date | 09/11/2015 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|