Cleared Traditional

VELLA 5% SODIUM FLUORIDE VARNISH WITH NUFLUOR AND XYLITOL

K140350 · Preventive Technologies, Inc. · Dental

Dec 2014

Decision

304d

Days

Class 2

Risk

About This 510(k) Submission

K140350 is an FDA 510(k) clearance for the VELLA 5% SODIUM FLUORIDE VARNISH WITH NUFLUOR AND XYLITOL, a Varnish, Cavity (Class II — Special Controls, product code LBH), submitted by Preventive Technologies, Inc. (Indian Trail, US). The FDA issued a Cleared decision on December 12, 2014, 304 days after receiving the submission on February 11, 2014. This device falls under the Dental review panel. Regulated under 21 CFR 872.3260.

Submission Details

510(k) Number	K140350 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 11, 2014
Decision Date	December 12, 2014
Days to Decision	304 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Statement