Device Classification Name |
bone grafting material, human source
|
510(k) Number |
K103699 |
Device Name |
EACTECH OPTECURE DENTAL AND OPTECURE DENTAL + CCC |
Applicant |
EXACTECH, INC. |
2320 N.W. 66TH CT. |
GAINESVILLE,
FL
32653
|
|
Applicant Contact |
SHING JEN TAI, PHD |
Correspondent |
EXACTECH, INC. |
2320 N.W. 66TH CT. |
GAINESVILLE,
FL
32653
|
|
Correspondent Contact |
SHING JEN TAI, PHD |
Regulation Number | 872.3930
|
Classification Product Code |
|
Date Received | 12/20/2010 |
Decision Date | 08/12/2011 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|