The following data is part of a premarket notification filed by Ultradent Products, Inc. with the FDA for Chlorcid, Chlorcid V, Chlorcid Surf.
Device ID | K173163 |
510k Number | K173163 |
Device Name: | ChlorCid, ChlorCid V, ChlorCid Surf |
Classification | Cleanser, Root Canal |
Applicant | Ultradent Products, Inc. 505 W Ultradent Drive (10200 South) South Jordan, UT 84095 |
Contact | Corey Jaseph |
Correspondent | Corey Jaseph Ultradent Products, Inc. 505 W Ultradent Drive (10200 South) South Jordan, UT 84095 |
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 | 2017-09-29 |
Decision Date | 2018-02-09 |
Summary: | summary |