Cleared Traditional

SODIUM HYPOCHLORITE 3 & 6% SOLUTION AND 6% WITH WETTING AGENTS TO LOWER SURFACE TENSION MARKETED AS CHLOR-XTRA

K082470 · Inter-Med, Inc. · Dental

Apr 2009

Decision

219d

Days

—

Risk

About This 510(k) Submission

K082470 is an FDA 510(k) clearance for the SODIUM HYPOCHLORITE 3 & 6% SOLUTION AND 6% WITH WETTING AGENTS TO LOWER SURFACE TENSION MARKETED AS CHLOR-XTRA, a Cleanser, Root Canal, submitted by Inter-Med, Inc. (Racine, US). The FDA issued a Cleared decision on April 3, 2009, 219 days after receiving the submission on August 27, 2008. This device falls under the Dental review panel.

Submission Details

510(k) Number	K082470 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 27, 2008
Decision Date	April 03, 2009
Days to Decision	219 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Summary PDF