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Recognized a 510(k)/PMA number — showing its clearance record and devices.

Clearance record K123731

BIOTENE ORAL BALANCE GEL, BIOTENE DRY MOUTH ORAL RINSE, BIOTENE MOISTURIZING MOUTH SPRAY · Glaxosmithkline Consumer Healthcare (Gskch) · decided 2013-01-04 (SESE)

FDA 510(k) database ↗Summary PDF ↗

Devices

BrandModelCompanyProduct codesPrimary DI
BioteneDry Mouth Gentle Oral RinseHaleon US Holdings LLCLFD00048582004566
BioteneDry Mouth Gentle Oral RinseHaleon US Holdings LLCLFD00048582004580
Biotene Oral Rinse Dry Mouth 1Haleon US Holdings LLCLFD00048582004405
BioteneOral Rinse Dry MouthHaleon US Holdings LLCLFD00048582802209
BioteneOral Rinse Twin PackHaleon US Holdings LLCLFD00048582350410
BioteneDry Mouth Oral RinseHaleon US Holdings LLCLFD00048582003309
BioteneEcommerce Variety Pack Rinse SprayHaleon US Holdings LLCLFD00048582120266
BioteneOral Rinse Twin PackHaleon US Holdings LLCLFD00048582285422
BioteneDry Mouth SampleHaleon US Holdings LLCLFD00048582100077