Device Classification Name |
Abutment, Implant, Dental, Endosseous
|
510(k) Number |
K071585 |
Device Name |
P.004 HEALING ABUTMENTS AND CLOSURE SCREWS |
Applicant |
STRAUMANN USA |
60 MINUTEMAN ROAD |
ANDOVER,
MA
01810
|
|
Applicant Contact |
ELAINE ALAN |
Correspondent |
STRAUMANN USA |
60 MINUTEMAN ROAD |
ANDOVER,
MA
01810
|
|
Correspondent Contact |
ELAINE ALAN |
Regulation Number | 872.3630
|
Classification Product Code |
|
Date Received | 06/11/2007 |
Decision Date | 07/11/2007 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|