The following data is part of a premarket notification filed by Austenal Dental, Inc. with the FDA for Light Cure Denture Glaze.
| Device ID | K871849 |
| 510k Number | K871849 |
| Device Name: | LIGHT CURE DENTURE GLAZE |
| Classification | Resin, Denture, Relining, Repairing, Rebasing |
| Applicant | AUSTENAL DENTAL, INC. 5101 S. KEELER AVE. Chicago, IL 60632 |
| Contact | Gilbert K Ntow |
| Correspondent | Gilbert K Ntow 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 | 1987-05-12 |
| Decision Date | 1987-08-10 |