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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 a medical device manufactured by Young Dental Manufacturing Co. 1, LLC. It received FDA 510(k) clearance on 2016-05-20 under approval 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. It is manufactured by Young Dental Manufacturing Co. 1, LLC. The 510(k) number is K153334.

When was Oral-B 5% Sodium Fluoride Varnish approved by the FDA?

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

What company makes Oral-B 5% Sodium Fluoride Varnish?

Oral-B 5% Sodium Fluoride Varnish is manufactured by Young Dental Manufacturing Co. 1, LLC.

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

NCT07556367 Post-Radiation Oral Health in Underserved Head and Neck Cancer Patients RECRUITING NCT07068204 Comparative Study of Caries-Preventive Effects: 2% Calcium Hypophosphite Toothpaste vs. Sodium Fluoride Toothpaste (1450ppm F) RECRUITING

Other Devices by Young Dental Manufacturing Co. 1, LLC

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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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