The following data is part of a premarket notification filed by Sandi-dent with the FDA for Sani-dent Denture Cleaner.
Device ID | K781779 |
510k Number | K781779 |
Device Name: | SANI-DENT DENTURE CLEANER |
Classification | Cleaner, Denture, Mechanical |
Applicant | SANDI-DENT 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | JER |
CFR Regulation Number | 872.3530 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1978-06-05 |
Decision Date | 1978-11-08 |