The following data is part of a premarket notification filed by Dental Research Laboratories with the FDA for Denture Cleansers.
Device ID | K872521 |
510k Number | K872521 |
Device Name: | DENTURE CLEANSERS |
Classification | Cleaner, Denture, Mechanical |
Applicant | DENTAL RESEARCH LABORATORIES 3095 ENISGLEN DR. Palm Harbor, FL 33563 |
Contact | Garblik, Dds |
Correspondent | Garblik, Dds DENTAL RESEARCH LABORATORIES 3095 ENISGLEN DR. Palm Harbor, FL 33563 |
Product Code | JER |
CFR Regulation Number | 872.3530 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-06-25 |
Decision Date | 1987-08-11 |