FDA 510(k)

Oral-B 5% 氟化钠凝胶

K号: K153334 · 2016-05-20

申请人Young Dental Manufacturing Co. 1, LLC

决定日期2016-05-20

产品代码LBH

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决定实质等同

器械摘要

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.

常见问题

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.

列明Young Dental Manufacturing Co. 1, LLC为申报人的其他记录

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