Device Classification Name |
alloy, gold-based noble metal
|
510(k) Number |
K891535 |
Device Name |
P-C PALLADIUM BASE DENTAL ALLOY |
Applicant |
MACDONALD METALS AND CERAMICS |
13519 1/2 ALONDRA BLVD. |
SANTA FE SPRINGS,
CA
90670
|
|
Applicant Contact |
RONALD A MACDONALD |
Correspondent |
MACDONALD METALS AND CERAMICS |
13519 1/2 ALONDRA BLVD. |
SANTA FE SPRINGS,
CA
90670
|
|
Correspondent Contact |
RONALD A MACDONALD |
Regulation Number | 872.3060
|
Classification Product Code |
|
Date Received | 03/17/1989 |
Decision Date | 04/12/1989 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|