Cleared Traditional

Apapro Desensitizer (K220419) - FDA 510(k) Clearance

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

K220419 · Sangi Co, Ltd. · Dental device
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Optimized for regulatory review, auditing and printing
Feb 2022
Decision
2d
Days
Class 2
Risk

K220419 is an FDA 510(k) clearance for the Apapro Desensitizer. Classified as Varnish, Cavity (product code LBH), Class II - Special Controls.

Submitted by Sangi Co, Ltd. (Tokyo, JP). The FDA issued a Cleared decision on February 16, 2022 after a review of 2 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Sangi Co, Ltd. devices

Submission Details

510(k) Number K220419 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 14, 2022
Decision Date February 16, 2022
Days to Decision 2 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
125d faster than avg
Panel avg: 127d · This submission: 2d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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

Third Party Review Group, LLC
Dave Yungvirt

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 27
Devices cleared under the same product code (LBH) and FDA review panel - the closest regulatory comparables to K220419.
Profisil Fluoride Varnish Combi pack (14801), Profisil Fluoride Varnish Normal pack mint (14802), Profisil Fluoride Varnish Normal pack berry (14804), Profisil Fluoride Varnish Normal pack unflavored (14806), Profisil Fluoride Varnish Sample pack (14800)
K230333 · Kettenbach GmbH & Co. KG · Jul 2023
Dental Desensitizer
K222891 · Guangzhou Beogene Biotech Co., Ltd. · May 2023
3M™ Clinpro™ Clear 2.1% Sodium Fluoride Treatment
K231338 · 3M Espe Dental Products · May 2023
BioMin Restore Plus
K200077 · Dr. Collins, Inc. · Nov 2020
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