| Device Classification Name |
Cement, Dental
|
| 510(k) Number |
K790127 |
| Device Name |
CEMENT, CERAMCO |
| Applicant |
| Johnson & Johnson Professionals, Inc. |
| 325 Paramount Dr. |
|
Raynham,
MA
02767
|
|
| Correspondent |
| Johnson & Johnson Professionals, Inc. |
| 325 Paramount Dr. |
|
Raynham,
MA
02767
|
|
| Regulation Number | 872.3275 |
| Classification Product Code |
|
| Date Received | 01/23/1979 |
| Decision Date | 02/26/1979 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
Dental
|
| 510k Review Panel |
Dental
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|