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FDA 510(k)

Oral-B 5% Sodium Fluoride Varnish

K-Number: K153334 · 2016-05-20

ApplicantYoung Dental Manufacturing Co. 1, LLC
Decision Date2016-05-20
Product CodeLBH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Oral-B 5% Sodium Fluoride Varnish is the device name listed in this FDA 510(k) record. The listed applicant is Young Dental Manufacturing Co. 1, LLC. It received FDA 510(k) clearance on 2016-05-20 under 510(k) number K153334. The device is classified under product code LBH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Oral-B 5% Sodium Fluoride Varnish?

Oral-B 5% Sodium Fluoride Varnish is a medical device that received FDA 510(k) clearance on 2016-05-20. The listed applicant is Young Dental Manufacturing Co. 1, LLC. The 510(k) number is K153334.

When did Oral-B 5% Sodium Fluoride Varnish receive FDA 510(k) clearance?

Oral-B 5% Sodium Fluoride Varnish received FDA 510(k) clearance on 2016-05-20, under 510(k) number K153334.

Who is the listed applicant for Oral-B 5% Sodium Fluoride Varnish?

The FDA 510(k) record lists Young Dental Manufacturing Co. 1, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Oral-B 5% Sodium Fluoride Varnish?

The FDA product code for Oral-B 5% Sodium Fluoride Varnish is LBH.

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.

NCT04528134Orthodontic Varnish Microbiology StudyCOMPLETEDNCT05395065Silver Diamine Fluoride Gel: Single Group Observational StudyCOMPLETEDNCT07286344Effect of Fluoride Varnish Formulation on the Management of Dentin HypersensitivityRECRUITINGNCT07556367Post-Radiation Oral Health in Underserved Head and Neck Cancer PatientsACTIVE_NOT_RECRUITING

Other records listing Young Dental Manufacturing Co. 1, LLC 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.

K241041Silver Fluoride Hypersensitivity VarnishK201127DEFEND Ear-loop Face MasksK171377Young INFINITY Cordless Handpiece System

Related Devices (Code: LBH)

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.

K253052Fluoride Varnish (Type A,Type C)Nagy Oral Technology Qinhuangdao Co., Ltd.K252073VOCO Profluorid Varnish + BioMinVoco GmbHK261404UltraEZUltradent Products, Inc.K260830APAPRO Desensitizer Homecare (Remineralizing Anti-sensitivity Toothpaste)Sangi Co., Ltd.K250714FluoroDose VarnishCentrix, Inc.K243777Rennou™ Varnish (3% / Spearmint); Rennou™ Varnish (3% / Strawberry); Rennou™ Varnish (3% / Cherry); Rennou™ Varnish (3% / Bubble Gum)Theodent, 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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