Cleared Traditional

K260830 - APAPRO Desensitizer Homecare (Remineralizing Anti-sensitivity Toothpaste) (FDA 510(k) Clearance)

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

K260830 · Sangi Co, Ltd. · Dental device
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Optimized for regulatory review, auditing and printing
Mar 2026
Decision
5d
Days
Class 2
Risk

K260830 is an FDA 510(k) clearance for the APAPRO Desensitizer Homecare (Remineralizing Anti-sensitivity Toothpaste). 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 March 18, 2026 after a review of 5 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 K260830 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 13, 2026
Decision Date March 18, 2026
Days to Decision 5 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
122d faster than avg
Panel avg: 127d · This submission: 5d
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 136
Devices cleared under the same product code (LBH) and FDA review panel - the closest regulatory comparables to K260830.
VOCO Profluorid Varnish + BioMin
K252073 · Voco GmbH · May 2026
UltraEZ
K261404 · Ultradent Products, Inc. · Apr 2026
FluoroDose Varnish
K250714 · Centrix, Inc. · Nov 2025
Rennou™ Varnish (3% / Spearmint)
K243777 · Theodent, LLC · May 2025
ReminGel
K241489 · Inter-Med, Inc. · Jan 2025
CrystLCare™ PRO Biorestorative, Fluoride-Plus
K241568 · GreenMark Biomedical, Inc. · Jan 2025