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FDA 510(k)

BIOTENE DRY MOUTH MOUTHWASH, BIOTENE PBF DRY MOUTH MOUTHWASH

K-Number: K101477 · 2010-09-28

ApplicantGlaxosmithkline Consumer Healthcare (Gskch)
Decision Date2010-09-28
Product CodeLFD
DecisionSubstantially Equivalent

Device Summary

BIOTENE DRY MOUTH MOUTHWASH, BIOTENE PBF DRY MOUTH MOUTHWASH is the device name listed in this FDA 510(k) record. The listed applicant is Glaxosmithkline Consumer Healthcare (Gskch). It received FDA 510(k) clearance on 2010-09-28 under 510(k) number K101477. The device is classified under product code LFD. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIOTENE DRY MOUTH MOUTHWASH, BIOTENE PBF DRY MOUTH MOUTHWASH?

BIOTENE DRY MOUTH MOUTHWASH, BIOTENE PBF DRY MOUTH MOUTHWASH is a medical device that received FDA 510(k) clearance on 2010-09-28. The listed applicant is Glaxosmithkline Consumer Healthcare (Gskch). The 510(k) number is K101477.

When did BIOTENE DRY MOUTH MOUTHWASH, BIOTENE PBF DRY MOUTH MOUTHWASH receive FDA 510(k) clearance?

BIOTENE DRY MOUTH MOUTHWASH, BIOTENE PBF DRY MOUTH MOUTHWASH received FDA 510(k) clearance on 2010-09-28, under 510(k) number K101477.

Who is the listed applicant for BIOTENE DRY MOUTH MOUTHWASH, BIOTENE PBF DRY MOUTH MOUTHWASH?

The FDA 510(k) record lists Glaxosmithkline Consumer Healthcare (Gskch) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BIOTENE DRY MOUTH MOUTHWASH, BIOTENE PBF DRY MOUTH MOUTHWASH?

The FDA product code for BIOTENE DRY MOUTH MOUTHWASH, BIOTENE PBF DRY MOUTH MOUTHWASH is LFD.

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Other records listing Glaxosmithkline Consumer Healthcare (Gskch) as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K123731BIOTENE ORAL BALANCE GEL, BIOTENE DRY MOUTH ORAL RINSE, BIOTENE MOISTURIZING MOUTH SPRAYK103745BIOTENE MOISTURIZING MOUTH SPRAY FOR DRY MOUTH SYMPTOM RELIEF

Related Devices (Code: LFD)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253778Allday Moisturizing RinseElevate Oral CareK250390CloSYS® Dry Mouth Sensitive Mouth RinseRowpar Pharmaceuticals, Inc.K240508Salivea Dry Mouth Moisturizing Gel (Dry Mouth Moisturizing Gel)Laclede, Inc.K234015Caphosol® Artifical Saliva (32 doses sachet box)Eusa Pharma (Uk) LimitedK231205GuruNanda Dry Mouth Oral Rinse and GuruNanda Dry Mouth Oral SprayGurunanda, LLCK202689Dentilube SprayOxy2plus, LLC

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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