BIOTENE DRY MOUTH MOUTHWASH, BIOTENE PBF DRY MOUTH MOUTHWASH— 510(k) K101477

Name: FDA 510(k) clearance K101477
Creator: U.S. Food and Drug Administration
Published: 2010-09-28

Substantially Equivalent

Glaxosmithkline Consumer Healthcare (Gskch)

FDA 510(k) clearance K101477 for BIOTENE DRY MOUTH MOUTHWASH, BIOTENE PBF DRY MOUTH MOUTHWASH, Substantially Equivalent on 2010-09-28. Applicant: Glaxosmithkline Consumer Healthcare (Gskch). Device class: Unclassified.

Clearance details

Applicant: Glaxosmithkline Consumer Healthcare (Gskch)
Product code: Code LFD
Device class: Unclassified
Advisory panel: Unknown
Date received: 2010-05-28
Decision date: 2010-09-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Parsippany, NJ, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code LFD

product code LFD

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 →

Data sourced from openFDA. This site is unofficial and independent of the FDA.