Device Classification Name |
Powder, Porcelain
|
510(k) Number |
K191794 |
Device Name |
Vintage Art Universal |
Applicant |
Shofu Dental Corporation |
1225 Stone Drive |
San Marcos,
CA
92078
|
|
Applicant Contact |
Mauro Malzyner |
Correspondent |
Shofu Dental Corporation |
1225 Stone Drive |
San Marcos,
CA
92078
|
|
Correspondent Contact |
Mauro Malzyner |
Regulation Number | 872.6660
|
Classification Product Code |
|
Date Received | 07/03/2019 |
Decision Date | 10/03/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|