Cleared Traditional

K253052 - Fluoride Varnish (Type A

K253052 is an FDA 510(k) clearance for Fluoride Varnish (Type A, manufactured by Nagy Oral Technology Qinhuangdao Co., Ltd.. The device is a Class 2 Dental device with product code LBH cleared through the Traditional 510(k) pathway after a 262-day FDA review.

K253052 · Nagy Oral Technology Qinhuangdao Co., Ltd. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2026
Decision
262d
Days
Class 2
Risk

K253052 is an FDA 510(k) clearance for the Fluoride Varnish (Type A,Type C). Classified as Varnish, Cavity (product code LBH), Class II - Special Controls.

Submitted by Nagy Oral Technology Qinhuangdao Co., Ltd. (Qinhuangdao, CN). The FDA issued a Cleared decision on June 11, 2026 after a review of 262 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 Nagy Oral Technology Qinhuangdao Co., Ltd. devices

FDA 510(k) Submission Details - K253052

510(k) Number K253052 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 22, 2025
Decision Date June 11, 2026
Days to Decision 262 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
135d slower than avg
Panel avg: 127d · This submission: 262d
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 81
Devices cleared under the same product code (LBH) and FDA review panel - the closest regulatory comparables to K253052.
VOCO Profluorid Varnish + BioMin
K252073 · Voco GmbH · May 2026
UltraEZ
K261404 · Ultradent Products, Inc. · Apr 2026
APAPRO Desensitizer Homecare (Remineralizing Anti-sensitivity Toothpaste)
K260830 · Sangi Co, Ltd. · Mar 2026
FluoroDose Varnish
K250714 · Centrix, Inc. · Nov 2025
Rennou™ Varnish (3% / Spearmint)
K243777 · Theodent, LLC · May 2025
ReminGel
K241489 · Inter-Med, Inc. · Jan 2025