Cleared Traditional

K192381 - DFV Desensitizing Varnish-Strawberry Fl...

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

K192381 · Scientific Pharmaceuticals · Dental device
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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

Submission Details

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.

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 70
Devices cleared under the same product code (LBH) and FDA review panel - the closest regulatory comparables to K192381.
Apapro Desensitizer
K220419 · Sangi Co, Ltd. · Feb 2022
BioMin Restore Plus
K200077 · Dr. Collins, Inc. · Nov 2020
FiteBac Antimicrobial Cavity Cleanser
K200614 · Largent Health, LLC · Jun 2020
Cervitec F
K191453 · Ivoclar Vivadent, AG · Feb 2020
FiteBac Cavity Cleanser
K190271 · Largent Health, LLC · Jan 2020
FluoroCal
K182917 · Bisco, Inc. · Nov 2019