Device Classification Name |
Barrier, Synthetic, Intraoral
|
510(k) Number |
K101956 |
Device Name |
STRAUMANN MEMBRAGEL |
Applicant |
STRAUMANN USA (ON BEHALF OF INSTITUT STRAUMANN AG) |
60 MINUTEMAN ROAD |
ANDOVER,
MA
01810
|
|
Applicant Contact |
JANET C KAY |
Correspondent |
STRAUMANN USA (ON BEHALF OF INSTITUT STRAUMANN AG) |
60 MINUTEMAN ROAD |
ANDOVER,
MA
01810
|
|
Correspondent Contact |
JANET C KAY |
Regulation Number | 872.3930
|
Classification Product Code |
|
Date Received | 07/12/2010 |
Decision Date | 12/16/2010 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|