Oral-B 5% Sodium Fluoride Varnish
FDA 510(k) K153334 · Young Dental Manufacturing Co. 1, LLC
510(k) numberK153334
Submission
- Device name
- Oral-B 5% Sodium Fluoride Varnish
- Applicant
- Young Dental Manufacturing Co. 1, LLC
Earth City, MO, US - Received
- November 19, 2015
- Decision date
- May 20, 2016
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Oral-B 5% Sodium Fluoride Varnish cleared by the FDA?
Oral-B 5% Sodium Fluoride Varnish (K153334) received a 510(k) decision of Substantially Equivalent on May 20, 2016, 183 days after the submission was received.
What is the product code of K153334?
The FDA product code is LBH – Varnish, Cavity, a Class II (moderate risk) device regulated under 21 CFR 872.3260.