Cleared Traditional

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

K112250 · Inter-Med, Inc. · Dental device
Oct 2011
Decision
85d
Days
-
Risk

K112250 is an FDA 510(k) clearance for the CHX=CHX PLUS. This device is classified as a Cleanser, Root Canal.

Submitted by Inter-Med, Inc. (Racine, US). The FDA issued a Cleared decision on October 28, 2011, 85 days after receiving the submission on August 4, 2011.

This device falls under the Dental FDA review panel.

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

Device Classification

Product Code KJJ - Cleanser, Root Canal
Device Class -