Fluorilaq Sodium Fluoride Cavity Varnish
FDA 510(k) K090597 · Pascal Co., Inc.
510(k) numberK090597
Submission
- Device name
- Fluorilaq Sodium Fluoride Cavity Varnish
- Applicant
- Pascal Co., Inc.
Bellevue, WA, US - Received
- March 5, 2009
- Decision date
- March 16, 2009
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Fluorilaq Sodium Fluoride Cavity Varnish cleared by the FDA?
Fluorilaq Sodium Fluoride Cavity Varnish (K090597) received a 510(k) decision of Substantially Equivalent on March 16, 2009, 11 days after the submission was received.
What is the product code of K090597?
The FDA product code is LBH – Varnish, Cavity, a Class II (moderate risk) device regulated under 21 CFR 872.3260.