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 |