Starbright 5% Sodium Fluoride Varnish
FDA 510(k) K140349 · Nanova Biomaterials, Inc.
510(k) numberK140349
Submission
- Device name
- Starbright 5% Sodium Fluoride Varnish
- Applicant
- Nanova Biomaterials, Inc.
Columbia, MO, US - Received
- February 19, 2014
- Decision date
- September 22, 2014
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Starbright 5% Sodium Fluoride Varnish cleared by the FDA?
Starbright 5% Sodium Fluoride Varnish (K140349) received a 510(k) decision of Substantially Equivalent on September 22, 2014, 215 days after the submission was received.
What is the product code of K140349?
The FDA product code is LBH – Varnish, Cavity, a Class II (moderate risk) device regulated under 21 CFR 872.3260.