Cleared Traditional

K140350 - VELLA 5% SODIUM FLUORIDE VARNISH WITH NUFLUOR AND XYLITOL

K140350 is an FDA 510(k) clearance for VELLA 5% SODIUM FLUORIDE VARNISH WITH N..., manufactured by Preventive Technologies, Inc.. The device is a Class 2 Dental device with product code LBH cleared through the Traditional 510(k) pathway after a 304-day FDA review.

K140350 · Preventive Technologies, Inc. · Dental device
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Dec 2014
Decision
304d
Days
Class 2
Risk

K140350 is an FDA 510(k) clearance for the VELLA 5% SODIUM FLUORIDE VARNISH WITH NUFLUOR AND XYLITOL. Classified as Varnish, Cavity (product code LBH), Class II - Special Controls.

Submitted by Preventive Technologies, Inc. (Indian Trail, US). The FDA issued a Cleared decision on December 12, 2014 after a review of 304 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3260 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Preventive Technologies, Inc. devices

FDA 510(k) Submission Details - K140350

510(k) Number K140350 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
177d slower than avg
Panel avg: 127d · This submission: 304d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LBH Device Classification - Class 2, Special Controls

Product Code LBH Varnish, Cavity
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3260
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.

Regulatory Peers - LBH Varnish, Cavity

All 101
Devices cleared under the same product code (LBH) and FDA review panel - the closest regulatory comparables to K140350.
Oral-B 5% Sodium Fluoride Varnish
K153334 · Young Dental Manufacturing Co. 1, LLC · May 2016
Clinpro Varnish
K151302 · 3M Company · Sep 2015
LISTERINE Sensitivity Defense Mouthrinse
K143155 · Johnson & Johnson Healthcare Products, Division of Mcneil-Pp · Jan 2015
FLUOR PROTECTOR S
K131487 · Ivoclar Vivadent, AG · Oct 2014
PROFLUORO FLUORIDE VARNISH
K141422 · Pac-Dent International, Inc. · Sep 2014
STARBRIGHT 5% SODIUM FLUORIDE VARNISH
K140349 · Nanova Biomaterials, Inc. · Sep 2014