| Device Classification Name |
Denture, Plastic, Teeth
|
| 510(k) Number |
K060720 |
| Device Name |
CURATIVE DENTAL ACRYLIC TEETH |
| Applicant |
| Curative, LLC |
| 49 Plain St. |
|
North Attleboro,
MA
02760
|
|
| Applicant Contact |
JAMES R VEALE |
| Correspondent |
| Curative, LLC |
| 49 Plain St. |
|
North Attleboro,
MA
02760
|
|
| Correspondent Contact |
JAMES R VEALE |
| Regulation Number | 872.3590 |
| Classification Product Code |
|
| Date Received | 03/17/2006 |
| Decision Date | 08/25/2006 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
Dental
|
| 510k Review Panel |
Dental
|
| Summary |
Summary
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|