Cleared Traditional

FiteBac Cavity Cleanser (K190271) - FDA 510(k) Clearance

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

K190271 · Largent Health, LLC · Dental device
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Jan 2020
Decision
349d
Days
Class 2
Risk

K190271 is an FDA 510(k) clearance for the FiteBac Cavity Cleanser. Classified as Varnish, Cavity (product code LBH), Class II - Special Controls.

Submitted by Largent Health, LLC (Marietta, US). The FDA issued a Cleared decision on January 23, 2020 after a review of 349 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 Largent Health, LLC devices

Submission Details

510(k) Number K190271 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 08, 2019
Decision Date January 23, 2020
Days to Decision 349 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
222d slower than avg
Panel avg: 127d · This submission: 349d
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 Consultant

Secure BioMed Evaluations
Elizabeth O'Keeffe

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - LBH Varnish, Cavity

All 32
Devices cleared under the same product code (LBH) and FDA review panel - the closest regulatory comparables to K190271.
FiteBac Antimicrobial Cavity Cleanser
K200614 · Largent Health, LLC · Jun 2020
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 · Scientific Pharmaceuticals · Feb 2020
Cervitec F
K191453 · Ivoclar Vivadent, AG · Feb 2020
FluoroCal
K182917 · Bisco, Inc. · Nov 2019
Restore Toothpaste
K181965 · Dr. Collins, Inc. · Jun 2019
Clinpro Varnish
K151302 · 3M Company · Sep 2015