The following data is part of a premarket notification filed by Austenal Dental, Inc. with the FDA for Austenal Hyco Alginate Impression Material.
| Device ID | K860911 |
| 510k Number | K860911 |
| Device Name: | AUSTENAL HYCO ALGINATE IMPRESSION MATERIAL |
| Classification | Material, Impression |
| Applicant | AUSTENAL DENTAL, INC. 5101 S. KEELER AVE. Chicago, IL 60632 |
| Contact | Hultan, D.d.s. |
| Correspondent | Hultan, D.d.s. AUSTENAL DENTAL, INC. 5101 S. KEELER AVE. Chicago, IL 60632 |
| Product Code | ELW |
| CFR Regulation Number | 872.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-03-11 |
| Decision Date | 1986-03-26 |