The following data is part of a premarket notification filed by Solar Dental Co., Inc. with the FDA for Dentolock Denture Adhesive Cream.
Device ID | K831265 |
510k Number | K831265 |
Device Name: | DENTOLOCK DENTURE ADHESIVE CREAM |
Classification | Adhesive, Denture, Carboxymethylcellulose Sodium (40-100&) |
Applicant | SOLAR DENTAL CO., INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | KOQ |
CFR Regulation Number | 872.3410 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-04-18 |
Decision Date | 1983-05-09 |