Device Classification Name |
Dental Amalgam
|
510(k) Number |
K140125 |
Device Name |
NEW STETIC DENTAL AMALGAM ALLOY |
Applicant |
NEW STETIC |
445 APOLLO BEACH BLVD |
APOLLO BEACH,
FL
33572
|
|
Applicant Contact |
JOHN O'BRIEN |
Correspondent |
NEW STETIC |
445 APOLLO BEACH BLVD |
APOLLO BEACH,
FL
33572
|
|
Correspondent Contact |
JOHN O'BRIEN |
Regulation Number | 872.3070
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 01/16/2014 |
Decision Date | 04/29/2014 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|