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Biotene Oral Balance Gel, Biotene Dry Mouth Oral Rinse, Biotene Moisturizing Mouth Spray

by Glaxosmithkline Consumer Healthcare (Gskch)

510(k) K123731

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK123731 Date4 Jan 2013ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-0272-2014 FDA Class II initiated 17 Oct 2013

    Label indicates, "Sweetened with xylitol and Sorbitol", however product does not contain sorbitol.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
LFD
Device Class
U
Advisory Committee
Unknown
FDA Decision
SESE Substantially Equivalent

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