The following data is part of a premarket notification filed by Den-mat Corp. with the FDA for Den-mat 4-minute Denture Cleaner.
Device ID | K791925 |
510k Number | K791925 |
Device Name: | DEN-MAT 4-MINUTE DENTURE CLEANER |
Classification | Cleaner, Denture, Mechanical |
Applicant | DEN-MAT CORP. 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | JER |
CFR Regulation Number | 872.3530 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1979-09-27 |
Decision Date | 1979-10-26 |