Cleared Traditional

K103745 - BIOTENE MOISTURIZING MOUTH SPRAY FOR DR...

K103745 · Glaxosmithkline Consumer Healthcare (Gskch) · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2011
Decision
209d
Days
-
Risk

K103745 is an FDA 510(k) clearance for the BIOTENE MOISTURIZING MOUTH SPRAY FOR DRY MOUTH SYMPTOM RELIEF. Classified as Saliva, Artificial (product code LFD).

Submitted by Glaxosmithkline Consumer Healthcare (Gskch) (Parsippany, US). The FDA issued a Cleared decision on July 20, 2011 after a review of 209 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 Glaxosmithkline Consumer Healthcare (Gskch) devices

FDA 510(k) Submission Details - K103745

510(k) Number K103745 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 23, 2010
Decision Date July 20, 2011
Days to Decision 209 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
82d slower than avg
Panel avg: 127d · This submission: 209d
Pathway characteristics
Predicate-based equivalence.

LFD Device Classification - Class 0,

Product Code LFD Saliva, Artificial
Device Class -

Regulatory Peers - LFD Saliva, Artificial

All 18
Devices cleared under the same product code (LFD) and FDA review panel - the closest regulatory comparables to K103745.
G•U•M HYDRAL Dry Mouth Oral Gel, G•U•M HYDRAL Dry Mouth Oral Rinse, G•U•M HYDRAL Dry Mouth Oral Spray
K181134 · Sunstar Americas, Inc. · Jul 2018
Moisyn Dry Mouth Oral Rinse, Moisyn Dry Mouth Oral Mist, Moisyn Free Dry Mouth Oral Rinse, Moisyn Free Dry Mouth Oral Mist
K173237 · Syendgen, Inc. · Mar 2018
TheraBreath Dry Mouth Oral Rinse, TheraBreath Dry Mouth Lozenges
K171542 · Dr. Harold Katz, LLC (Dba Therabreath · Mar 2018
GC ORAL MOISTURIZING GEL
K101346 · GC America, Inc. · Jan 2011
GLANDOSANE (SALIVART) SYNTHETIC SALIVA
K874106 · Fresenius USA, Inc. · Apr 1988