The following data is part of a premarket notification filed by Dentalmatic Technologies, Inc. with the FDA for Dentalmatic Ti Prosthesis And Dentalmatic Ti-a Prosthetic.
| Device ID | K001269 |
| 510k Number | K001269 |
| Device Name: | DENTALMATIC TI PROSTHESIS AND DENTALMATIC TI-A PROSTHETIC |
| Classification | Alloy, Metal, Base |
| Applicant | DENTALMATIC TECHNOLOGIES, INC. 9710 TRANSCANADA HIGHWAY ST St Laurent, Qc, CA H4s 1v9 |
| Contact | Naoum Araj |
| Correspondent | Naoum Araj DENTALMATIC TECHNOLOGIES, INC. 9710 TRANSCANADA HIGHWAY ST St Laurent, Qc, CA H4s 1v9 |
| Product Code | EJH |
| CFR Regulation Number | 872.3710 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-04-20 |
| Decision Date | 2000-06-21 |