The following data is part of a premarket notification filed by Septodont with the FDA for Plastalgin And Plastalgin Ortho.
| Device ID | K032708 |
| 510k Number | K032708 |
| Device Name: | PLASTALGIN AND PLASTALGIN ORTHO |
| Classification | Material, Impression |
| Applicant | SEPTODONT 1050 CONNECTICUT AVE., NW Washington, DC 20036 |
| Contact | Wayne H Matelski, Esq. |
| Correspondent | Wayne H Matelski, Esq. SEPTODONT 1050 CONNECTICUT AVE., NW Washington, DC 20036 |
| Product Code | ELW |
| CFR Regulation Number | 872.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-09-02 |
| Decision Date | 2003-11-20 |