Cleared Traditional

BIOTENE MOISTURIZING MOUTH SPRAY FOR DRY MOUTH SYMPTOM RELIEF (K103745) - FDA 510(k) Clearance

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

Submission Details

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.

Device Classification

Product Code LFD Saliva, Artificial
Device Class -

Regulatory Peers - LFD Saliva, Artificial

All 49
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