The following data is part of a premarket notification filed by Austenal Dental, Inc. with the FDA for Austenal Acusoft Soft Liner.
| Device ID | K862557 |
| 510k Number | K862557 |
| Device Name: | AUSTENAL ACUSOFT SOFT LINER |
| Classification | Resin, Denture, Relining, Repairing, Rebasing |
| Applicant | AUSTENAL DENTAL, INC. 5101 S. KEELER AVE. Chicago, IL 60632 |
| Contact | Ronald P Dudek |
| Correspondent | Ronald P Dudek AUSTENAL DENTAL, INC. 5101 S. KEELER AVE. Chicago, IL 60632 |
| Product Code | EBI |
| CFR Regulation Number | 872.3760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-07-03 |
| Decision Date | 1987-02-19 |