Cleared Special

K123731 - BIOTENE ORAL BALANCE GEL, BIOTENE DRY MOUTH ORAL RINSE, BIOTENE MOISTURIZING MOUTH SPRAY

K123731 · Glaxosmithkline Consumer Healthcare (Gskch) · Dental device
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Jan 2013
Decision
30d
Days
-
Risk

K123731 is an FDA 510(k) clearance for the BIOTENE ORAL BALANCE GEL, BIOTENE DRY MOUTH ORAL RINSE, BIOTENE MOISTURIZING .... Classified as Saliva, Artificial (product code LFD).

Submitted by Glaxosmithkline Consumer Healthcare (Gskch) (Parsippany, US). The FDA issued a Cleared decision on January 4, 2013 after a review of 30 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Glaxosmithkline Consumer Healthcare (Gskch) devices

FDA 510(k) Submission Details - K123731

510(k) Number K123731 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 05, 2012
Decision Date January 04, 2013
Days to Decision 30 days
Submission Type Special
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
98d faster than avg
Panel avg: 128d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

LFD Device Classification - Class 0,

Product Code LFD Saliva, Artificial
Device Class -

Regulatory Peers - LFD Saliva, Artificial

All 43
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