The following data is part of a premarket notification filed by Austenal, Inc. with the FDA for Denture Plastic Teeth.
| Device ID | K924526 |
| 510k Number | K924526 |
| Device Name: | DENTURE PLASTIC TEETH |
| Classification | Denture, Plastic, Teeth |
| Applicant | AUSTENAL, INC. 4101 WEST 51ST ST. Chicago, IL 60632 -4287 |
| Contact | Ronald Dudek |
| Correspondent | Ronald Dudek AUSTENAL, INC. 4101 WEST 51ST ST. Chicago, IL 60632 -4287 |
| Product Code | ELM |
| CFR Regulation Number | 872.3590 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-09-08 |
| Decision Date | 1992-11-04 |