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FDA 510(k)

Oral-B Dry Mouth Oral Rinse

K-Number: K201277 · 2020-09-02

ApplicantThe Procter & Gamble Company
Decision Date2020-09-02
Product CodeLFD
DecisionSubstantially Equivalent

Device Summary

Oral-B Dry Mouth Oral Rinse is the device name listed in this FDA 510(k) record. The listed applicant is The Procter & Gamble Company. It received FDA 510(k) clearance on 2020-09-02 under 510(k) number K201277. The device is classified under product code LFD. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Oral-B Dry Mouth Oral Rinse?

Oral-B Dry Mouth Oral Rinse is a medical device that received FDA 510(k) clearance on 2020-09-02. The listed applicant is The Procter & Gamble Company. The 510(k) number is K201277.

When did Oral-B Dry Mouth Oral Rinse receive FDA 510(k) clearance?

Oral-B Dry Mouth Oral Rinse received FDA 510(k) clearance on 2020-09-02, under 510(k) number K201277.

Who is the listed applicant for Oral-B Dry Mouth Oral Rinse?

The FDA 510(k) record lists The Procter & Gamble Company as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Oral-B Dry Mouth Oral Rinse?

The FDA product code for Oral-B Dry Mouth Oral Rinse is LFD.

Related Clinical Trials

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.

NCT00540774Optical Sensor for Photodynamic Detection of Oral PathologyCOMPLETEDNCT05401201Dual-light Antibacterial Photodynamic Therapy as an Adjunctive Treatment to Corticosteroid Treatment in OLPCOMPLETEDNCT07506018MucoLock™ for Treatment of StomatitisRECRUITINGNCT07511335Dry Needling Versus Stabilization Splint Therapy in Bruxism Associated Myofascial Temporomandibular DisordersCOMPLETEDNCT07564843Theravex® for Burning Mouth SyndromeCOMPLETEDNCT07593495Application of Neuro-electrostimulation as a Treatment for Patients With Dry MouthRECRUITING

Other records listing The Procter & Gamble Company 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.

K203567Oral-B Dry Mouth Oral RinseK200881Oral-B iO Test Drive Power Brush Trial Program Kit

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

View on FDA Database →

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

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