| Device Classification Name |
Powder, Porcelain
|
| 510(k) Number |
K855037 |
| Device Name |
TRU-COLOR |
| Applicant |
| Veritas Dental Co., Inc. |
| 10 Hawthorn Pl. |
|
Bosten,
MA
02114
|
|
| Applicant Contact |
STEWART LUSTGARTON |
| Correspondent |
| Veritas Dental Co., Inc. |
| 10 Hawthorn Pl. |
|
Bosten,
MA
02114
|
|
| Correspondent Contact |
STEWART LUSTGARTON |
| Regulation Number | 872.6660 |
| Classification Product Code |
|
| Date Received | 12/13/1985 |
| Decision Date | 03/06/1986 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
Dental
|
| 510k Review Panel |
Dental
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|