The following data is part of a premarket notification filed by Austenal Dental, Inc. with the FDA for Austenal Condensing Instrument.
| Device ID | K865025 |
| 510k Number | K865025 |
| Device Name: | AUSTENAL CONDENSING INSTRUMENT |
| Classification | Condenser, Amalgam And Foil, Operative |
| Applicant | AUSTENAL DENTAL, INC. 5101 S. KEELER AVE. Chicago, IL 60632 |
| Contact | Johan Hulten |
| Correspondent | Johan Hulten AUSTENAL DENTAL, INC. 5101 S. KEELER AVE. Chicago, IL 60632 |
| Product Code | EKG |
| CFR Regulation Number | 872.4565 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-12-23 |
| Decision Date | 1987-02-19 |