| Device Classification Name |
Alloy, Amalgam
|
| 510(k) Number |
K771383 |
| Device Name |
ALLOY DISPOS-A-CAP DENTAL SCHOOL CAP |
| Applicant |
| Johnson & Johnson Professionals, Inc. |
| 325 Paramount Dr. |
|
Raynham,
MA
02767
|
|
| Correspondent |
| Johnson & Johnson Professionals, Inc. |
| 325 Paramount Dr. |
|
Raynham,
MA
02767
|
|
| Regulation Number | 872.3070 |
| Classification Product Code |
|
| Date Received | 07/27/1977 |
| Decision Date | 08/03/1977 |
| 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
|
|
|