Cleared Traditional

CHX=CHX PLUS (K112250) - FDA 510(k) Clearance

K112250 · Inter-Med, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2011
Decision
85d
Days
-
Risk

K112250 is an FDA 510(k) clearance for the CHX=CHX PLUS. Classified as Cleanser, Root Canal (product code KJJ).

Submitted by Inter-Med, Inc. (Racine, US). The FDA issued a Cleared decision on October 28, 2011 after a review of 85 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Inter-Med, Inc. devices

Submission Details

510(k) Number K112250 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 04, 2011
Decision Date October 28, 2011
Days to Decision 85 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
42d faster than avg
Panel avg: 127d · This submission: 85d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KJJ Cleanser, Root Canal
Device Class -

Regulatory Peers - KJJ Cleanser, Root Canal

All 11
Devices cleared under the same product code (KJJ) and FDA review panel - the closest regulatory comparables to K112250.
RC-Prime Root Canal Preparation Cream
K200330 · Pac-Dent, Inc. · Jul 2020
ChlorCid, ChlorCid V, ChlorCid Surf
K173163 · Ultradent Products, Inc. · Feb 2018
Straumann PrefGel
K162311 · Institut Straumann AG · Mar 2017
ENDOPURE ROOT CANAL CLEANSER
K032361 · Dentsply Intl. · Jan 2004
CLEANSER, ROOT CANAL
K802853 · Dentsply Intl. · Dec 1980