Cleared Traditional

K082470 - SODIUM HYPOCHLORITE 3 & 6% SOLUTION AND...

K082470 · Inter-Med, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2009
Decision
219d
Days
-
Risk

K082470 is an FDA 510(k) clearance for the SODIUM HYPOCHLORITE 3 & 6% SOLUTION AND 6% WITH WETTING AGENTS TO LOWER SURFA.... Classified as Cleanser, Root Canal (product code KJJ).

Submitted by Inter-Med, Inc. (Racine, US). The FDA issued a Cleared decision on April 3, 2009 after a review of 219 days - an extended review 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: 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 Inter-Med, Inc. devices

FDA 510(k) Submission Details - K082470

510(k) Number K082470 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
92d slower than avg
Panel avg: 127d · This submission: 219d
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 18
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STRAUMANN PREFGEL
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FILE-EZE
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