Cleared Traditional

K103745 - BIOTENE MOISTURIZING MOUTH SPRAY FOR DRY MOUTH SYMPTOM RELIEF

K103745 · Glaxosmithkline Consumer Healthcare (Gskch) · Dental device
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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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
81d slower than avg
Panel avg: 128d · 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 44
Devices cleared under the same product code (LFD) and FDA review panel - the closest regulatory comparables to K103745.
BIOTENE ORAL BALANCE GEL, BIOTENE DRY MOUTH ORAL RINSE, BIOTENE MOISTURIZING MOUTH SPRAY
K123731 · Glaxosmithkline Consumer Healthcare (Gskch) · Jan 2013
AIR LIFT/XEROSTOM ARTIFICIAL SALIVA
K120552 · Biocosmetics Laboratories · Jun 2012
DRY MOUTH MOUTHWASH
K111250 · Dr. Fresh, Inc. · Apr 2012
XEROS DRY MOUTH PUMP
K110116 · Lorin Technologies Corporation · Apr 2011
GC ORAL MOISTURIZING GEL
K101346 · GC America, Inc. · Jan 2011
BIOTENE DRY MOUTH MOUTHWASH, BIOTENE PBF DRY MOUTH MOUTHWASH
K101477 · Glaxosmithkline Consumer Healthcare (Gskch) · Sep 2010