Cleared Traditional

K173163 - ChlorCid, ChlorCid V, ChlorCid Surf

K173163 · Ultradent Products, Inc. · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (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.

FDA 510(k) Submission Details - K173163

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
5d slower than avg
Panel avg: 128d · This submission: 133d
Pathway characteristics
Predicate-based equivalence.

KJJ Device Classification - Class 0,

Product Code KJJ Cleanser, Root Canal
Device Class -

Regulatory Peers - KJJ Cleanser, Root Canal

All 36
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