Device Classification Name |
Abutment, Implant, Dental, Endosseous
|
510(k) Number |
K063106 |
Device Name |
REVOIS IMPLANT SYSTEM |
Applicant |
CURASAN AG |
109 SHORE DRIVE |
GARNER,
NC
27529
|
|
Applicant Contact |
ERIC WEICHERT |
Correspondent |
CURASAN AG |
109 SHORE DRIVE |
GARNER,
NC
27529
|
|
Correspondent Contact |
ERIC WEICHERT |
Regulation Number | 872.3630
|
Classification Product Code |
|
Date Received | 10/11/2006 |
Decision Date | 06/11/2007 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Abbreviated
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|