Cleared Traditional

K173163 - ChlorCid, ChlorCid V, ChlorCid Surf (FDA 510(k) Clearance)

K173163 · Ultradent Products, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2018
Decision
133d
Days
-
Risk

K173163 is an FDA 510(k) clearance for the ChlorCid, ChlorCid V, ChlorCid Surf. Classified as Cleanser, Root Canal (product code KJJ).

Submitted by Ultradent Products, Inc. (South Jordan, US). The FDA issued a Cleared decision on February 9, 2018 after a review of 133 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Ultradent Products, Inc. devices

Submission Details

510(k) Number K173163 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 2017
Decision Date February 09, 2018
Days to Decision 133 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
6d slower than avg
Panel avg: 127d · This submission: 133d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KJJ Cleanser, Root Canal
Device Class -

Regulatory Peers - KJJ Cleanser, Root Canal

All 40
Devices cleared under the same product code (KJJ) and FDA review panel - the closest regulatory comparables to K173163.
RC-SwiftPrep
K250279 · Belport Company, Inc., Gingi-Pak · Jul 2025
Sealer Solvent
K241354 · Inter-Med, Inc. · Aug 2024
EPIEN Dental Cleanser
K201785 · Epien Medical, Inc. · Sep 2021
Triton
K211813 · Inter-Med / Vista Dental · Aug 2021
V-Mix
K193357 · Inter-Med/Vista Dental Products · Oct 2020
Vista Rinse, Vista Rinse Plus
K193409 · Inter-Med/Vista Dental Products · Sep 2020