The following data is part of a premarket notification filed by Inter-med/vista Dental Products with the FDA for Vista Rinse, Vista Rinse Plus.
Device ID | K193409 |
510k Number | K193409 |
Device Name: | Vista Rinse, Vista Rinse Plus |
Classification | Cleanser, Root Canal |
Applicant | Inter-Med/Vista Dental Products 2200 South St. Ste. A Racine, WI 53404 |
Contact | Alex Johnson |
Correspondent | Alex Johnson Inter-Med/Vista Dental Products 2200 South St. Ste. A Racine, WI 53404 |
Product Code | KJJ |
CFR Regulation Number | 510(k) Premarket Notification [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2019-12-09 |
Decision Date | 2020-09-09 |