The following data is part of a premarket notification filed by Vident with the FDA for V.r.s. Denture Resin Material.
Device ID | K962333 |
510k Number | K962333 |
Device Name: | V.R.S. DENTURE RESIN MATERIAL |
Classification | Resin, Denture, Relining, Repairing, Rebasing |
Applicant | VIDENT 3150 EAST BIRCH ST. Brea, CA 92821 |
Contact | Ray E Morrow |
Correspondent | Ray E Morrow VIDENT 3150 EAST BIRCH ST. Brea, CA 92821 |
Product Code | EBI |
CFR Regulation Number | 872.3760 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-06-17 |
Decision Date | 1996-08-07 |