Cleared Traditional

K140350 - VELLA 5% SODIUM FLUORIDE VARNISH WITH NUFLUOR AND XYLITOL (FDA 510(k) Clearance)

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

Submission Details

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
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.

Device Classification

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 136
Devices cleared under the same product code (LBH) and FDA review panel - the closest regulatory comparables to K140350.
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K241489 · Inter-Med, Inc. · Jan 2025