Profluoro Fluoride Varnish
FDA 510(k) K141422 · Pac-Dent International, Inc.
510(k) numberK141422
Submission
- Device name
- Profluoro Fluoride Varnish
- Applicant
- Pac-Dent International, Inc.
Walnut, CA, US - Received
- May 30, 2014
- Decision date
- September 30, 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 Profluoro Fluoride Varnish cleared by the FDA?
Profluoro Fluoride Varnish (K141422) received a 510(k) decision of Substantially Equivalent on September 30, 2014, 123 days after the submission was received.
What is the product code of K141422?
The FDA product code is LBH – Varnish, Cavity, a Class II (moderate risk) device regulated under 21 CFR 872.3260.