The following data is part of a premarket notification filed by Denture Dynamic's, Inc. with the FDA for Denture Dynamic's Denture Magic.
Device ID | K902838 |
510k Number | K902838 |
Device Name: | DENTURE DYNAMIC'S DENTURE MAGIC |
Classification | Cleanser, Denture, Over The Counter |
Applicant | DENTURE DYNAMIC'S, INC. 4785 RIVER RD. N. Keizer, OR 97303 |
Contact | Doug Watkins |
Correspondent | Doug Watkins DENTURE DYNAMIC'S, INC. 4785 RIVER RD. N. Keizer, OR 97303 |
Product Code | EFT |
CFR Regulation Number | 872.3520 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-06-28 |
Decision Date | 1990-09-06 |