Cleared Traditional

K101346 - GC ORAL MOISTURIZING GEL

K101346 · GC America, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2011
Decision
259d
Days
-
Risk

K101346 is an FDA 510(k) clearance for the GC ORAL MOISTURIZING GEL. Classified as Saliva, Artificial (product code LFD).

Submitted by GC America, Inc. (Alsip, US). The FDA issued a Cleared decision on January 27, 2011 after a review of 259 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 GC America, Inc. devices

Submission Details

510(k) Number K101346 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 13, 2010
Decision Date January 27, 2011
Days to Decision 259 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
132d slower than avg
Panel avg: 127d · This submission: 259d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LFD Saliva, Artificial
Device Class -

Regulatory Peers - LFD Saliva, Artificial

All 16
Devices cleared under the same product code (LFD) and FDA review panel - the closest regulatory comparables to K101346.
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TheraBreath Dry Mouth Oral Rinse, TheraBreath Dry Mouth Lozenges
K171542 · Dr. Harold Katz, LLC (Dba Therabreath · Mar 2018