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 |