The following data is part of a premarket notification filed by Austenal Dental, Inc. with the FDA for Austenal Modified Acrylic Denture Resin.
| Device ID | K853160 |
| 510k Number | K853160 |
| Device Name: | AUSTENAL MODIFIED ACRYLIC DENTURE RESIN |
| Classification | Denture, Plastic, Teeth |
| Applicant | AUSTENAL DENTAL, INC. 5101 S. KEELER AVE. Chicago, IL 60632 |
| Contact | Roger Mola |
| Correspondent | Roger Mola AUSTENAL DENTAL, INC. 5101 S. KEELER AVE. Chicago, IL 60632 |
| Product Code | ELM |
| CFR Regulation Number | 872.3590 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-07-30 |
| Decision Date | 1985-10-31 |