The following data is part of a premarket notification filed by Manufacturera Dental Continental with the FDA for Nic Tone Acrylic Resins.
| Device ID | K991577 |
| 510k Number | K991577 |
| Device Name: | NIC TONE ACRYLIC RESINS |
| Classification | Resin, Denture, Relining, Repairing, Rebasing |
| Applicant | MANUFACTURERA DENTAL CONTINENTAL 30001 GOLDEN HARTERN #334 Haguna Nyvel, CA 92677 |
| Contact | Gary Mocnik |
| Correspondent | Gary Mocnik MANUFACTURERA DENTAL CONTINENTAL 30001 GOLDEN HARTERN #334 Haguna Nyvel, CA 92677 |
| Product Code | EBI |
| Subsequent Product Code | EBG |
| Subsequent Product Code | OCL |
| CFR Regulation Number | 872.3760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-05-06 |
| Decision Date | 1999-09-22 |