The following data is part of a premarket notification filed by Dental-material Gesellschaft with the FDA for Polyvinyl Silicone Impression Material.
| Device ID | K810825 |
| 510k Number | K810825 |
| Device Name: | POLYVINYL SILICONE IMPRESSION MATERIAL |
| Classification | Material, Impression |
| Applicant | DENTAL-MATERIAL GESELLSCHAFT 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | ELW |
| CFR Regulation Number | 872.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-03-24 |
| Decision Date | 1981-04-14 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| EDMG9997658 | K810825 | 000 |
| 00841549115950 | K810825 | 000 |
| 00841549115943 | K810825 | 000 |
| 00841549115936 | K810825 | 000 |
| 00841549115929 | K810825 | 000 |
| 00841549115912 | K810825 | 000 |
| 00841549115905 | K810825 | 000 |