The following data is part of a premarket notification filed by Davis Schottlander & Davis, Ltd. with the FDA for Enigma Denture Teeth.
| Device ID | K984128 |
| 510k Number | K984128 |
| Device Name: | ENIGMA DENTURE TEETH |
| Classification | Denture, Plastic, Teeth |
| 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 | ELM |
| CFR Regulation Number | 872.3590 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-11-18 |
| Decision Date | 1999-02-09 |