Cleared Traditional

K192381 - DFV Desensitizing Varnish-Strawberry Flavor, DFV Desensitizing Varnish-Bubblegum (Tutti-Fruity) Flavor, DFV Desensitizing Varnish-Spearmint Flavor, DFV Desensitizing Varnish-Chocolate Flavor, DFV Desensitizing Varnish-Marshmallow Flavor

K192381 is an FDA 510(k) clearance for DFV Desensitizing Varnish-Strawberry Flavor, manufactured by Scientific Pharmaceuticals. The device is a Class 2 Dental device with product code LBH cleared through the Traditional 510(k) pathway after a 172-day FDA review.

K192381 · Scientific Pharmaceuticals · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2020
Decision
172d
Days
Class 2
Risk

K192381 is an FDA 510(k) clearance for the DFV Desensitizing Varnish-Strawberry Flavor, DFV Desensitizing Varnish-Bubble.... Classified as Varnish, Cavity (product code LBH), Class II - Special Controls.

Submitted by Scientific Pharmaceuticals (Pomona, US). The FDA issued a Cleared decision on February 18, 2020 after a review of 172 days - an extended review cycle.

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. Standard predicate reliance. 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 Scientific Pharmaceuticals devices

FDA 510(k) Submission Details - K192381

510(k) Number K192381 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 30, 2019
Decision Date February 18, 2020
Days to Decision 172 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
45d slower than avg
Panel avg: 127d · This submission: 172d
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 K192381.
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Cervitec F
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FiteBac Cavity Cleanser
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FluoroCal
K182917 · Bisco, Inc. · Nov 2019