BIOTENE MOISTURIZING MOUTH SPRAY FOR DRY MOUTH SYMPTOM RELIEF— 510(k) K103745

Clearance details

Applicant

Glaxosmithkline Consumer Healthcare (Gskch)

Product code

Code LFD

Device class

Unclassified

Advisory panel

Unknown

Date received

2010-12-23

Decision date

2011-07-20

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Parsippany, NJ, US

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• K231205 — GuruNanda Dry Mouth Oral Rinse and GuruNanda Dry Mouth Oral Spray2023-08-22

• K123731 — BIOTENE ORAL BALANCE GEL, BIOTENE DRY MOUTH ORAL RINSE, BIOTENE MOISTURIZING MOUTH SPRAY2013-01-04
• 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 →