Device Classification Name |
alloy, amalgam
|
510(k) Number |
K020452 |
Device Name |
HIGH SILVER CONVENTIONAL |
Applicant |
AB ARDENT |
54 RIVERVIEW AVE. |
TONAWANDA,
NY
14150 -5260
|
|
Applicant Contact |
CLYDE E INGERSOLL |
Correspondent |
AB ARDENT |
54 RIVERVIEW AVE. |
TONAWANDA,
NY
14150 -5260
|
|
Correspondent Contact |
CLYDE E INGERSOLL |
Regulation Number | 872.3070
|
Classification Product Code |
|
Date Received | 02/11/2002 |
Decision Date | 05/07/2002 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|