Device Classification Name |
material, impression
|
510(k) Number |
K801380 |
Device Name |
CROWN DELTA SILICONE IMPRESSION MATERIAL |
Applicant |
CROWN DELTA CORP. |
4221 Richmond Rd., N.W. |
Walker,
MI
49534
|
|
Correspondent |
CROWN DELTA CORP. |
4221 Richmond Rd., N.W. |
Walker,
MI
49534
|
|
Regulation Number | 872.3660
|
Classification Product Code |
|
Date Received | 06/11/1980 |
Decision Date | 07/08/1980 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|