| Device Classification Name |
Alloy, Metal, Base
|
| 510(k) Number |
K001269 |
| Device Name |
DENTALMATIC TI PROSTHESIS AND DENTALMATIC TI-A PROSTHETIC |
| Applicant |
| Dentalmatic Technologies, Inc. |
| 9710 Transcanada Hwy. St. |
|
St Laurent, Qc,
CA
H4S 1V9
|
|
| Applicant Contact |
NAOUM ARAJ |
| Correspondent |
| Dentalmatic Technologies, Inc. |
| 9710 Transcanada Hwy. St. |
|
St Laurent, Qc,
CA
H4S 1V9
|
|
| Correspondent Contact |
NAOUM ARAJ |
| Regulation Number | 872.3710 |
| Classification Product Code |
|
| Date Received | 04/20/2000 |
| Decision Date | 06/21/2000 |
| 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
|
|
|