| Device Classification Name |
Resin, Denture, Relining, Repairing, Rebasing
|
| 510(k) Number |
K902972 |
| Device Name |
FLEXOR (DENTURE ACRYLIC RELINE MATERIAL) |
| Applicant |
| Cmp Industries, LLC |
| P.O. Box 350 |
|
Albany,
NY
12201
|
|
| Applicant Contact |
WILLIAM REGAN |
| Correspondent |
| Cmp Industries, LLC |
| P.O. Box 350 |
|
Albany,
NY
12201
|
|
| Correspondent Contact |
WILLIAM REGAN |
| Regulation Number | 872.3760 |
| Classification Product Code |
|
| Date Received | 07/06/1990 |
| Decision Date | 10/04/1990 |
| 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
|
|
|