Device Classification Name |
cement, dental |
|||
---|---|---|---|---|
510(k) Number | K121804 | |||
Device Name | PROVITEMP, DENTOTEMP, TOTALCEM, DENTOCEM | |||
Applicant |
|
|||
Applicant Contact | louis paul marin | |||
Correspondent |
|
|||
Correspodent Contact | louis paul marin | |||
Regulation Number | 872.3275 | |||
Classification Product Code |
|
|||
Date Received | 06/19/2012 | |||
Decision Date | 04/19/2013 | |||
Decision |
substantially equivalent (SESE) |
|||
Regulation Medical Specialty |
Dental |
|||
510k Review Panel |
Dental |
|||
summary |
summary |
|||
Type | Abbreviated | |||
Reviewed by Third Party | No | |||
Combination Product |
No |