The following data is part of a premarket notification filed by Davis Schottlander & Davis, Ltd. with the FDA for Enigma Hi-base Denture Base Material.
| Device ID | K993717 |
| 510k Number | K993717 |
| Device Name: | ENIGMA HI-BASE DENTURE BASE MATERIAL |
| Classification | Resin, Denture, Relining, Repairing, Rebasing |
| Applicant | DAVIS SCHOTTLANDER & DAVIS, LTD. 54 RIVERVIEW AVE. Tonawanda, NY 14150 -5260 |
| Contact | Clyde E Ingersoll |
| Correspondent | Clyde E Ingersoll DAVIS SCHOTTLANDER & DAVIS, LTD. 54 RIVERVIEW AVE. Tonawanda, NY 14150 -5260 |
| Product Code | EBI |
| CFR Regulation Number | 872.3760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-11-03 |
| Decision Date | 1999-12-22 |