The following data is part of a premarket notification filed by Bauer, Cheng & Associates, Inc. with the FDA for Isosit Teeth.
| Device ID | K810970 |
| 510k Number | K810970 |
| Device Name: | ISOSIT TEETH |
| Classification | Denture, Plastic, Teeth |
| Applicant | BAUER, CHENG & ASSOCIATES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | ELM |
| CFR Regulation Number | 872.3590 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-04-09 |
| Decision Date | 1981-05-05 |