BIOTENE ORAL BALANCE GEL, BIOTENE DRY MOUTH ORAL RINSE, BIOTENE MOISTURIZING MOUTH SPRAY— 510(k) K123731

Clearance details

Applicant

Glaxosmithkline Consumer Healthcare (Gskch)

Product code

Code LFD

Device class

Unclassified

Advisory panel

Unknown

Date received

2012-12-05

Decision date

2013-01-04

Decision

Substantially Equivalent

Clearance type

Special

Location

Parsippany, NJ, US

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• K240508 — Salivea Dry Mouth Moisturizing Gel (Dry Mouth Moisturizing Gel)2024-04-19
• K234015 — Caphosol® Artifical Saliva (32 doses sachet box)2024-03-11
• K231205 — GuruNanda Dry Mouth Oral Rinse and GuruNanda Dry Mouth Oral Spray2023-08-22

• K103745 — BIOTENE MOISTURIZING MOUTH SPRAY FOR DRY MOUTH SYMPTOM RELIEF2011-07-20
• K101477 — BIOTENE DRY MOUTH MOUTHWASH, BIOTENE PBF DRY MOUTH MOUTHWASH2010-09-28

Death

3

Total

3

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• Z-0272-2014 — Biotene Moisturizing Mouth Spray, with xylitol, For dry mouth symptom relief, 44.3ml/1.5 FL. OZ., Sugar Free Sweetened with xylitol and sorbitol, GlaxoSmithKline, Consumer Healthcare, L.P., Moon Township, PA 15108. Biotene Mouth Spray is used for the treatment of dry mouthClass II·Terminated·GlaxoSmithKline, LLC.·20131017

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K123731.