Cleared Traditional

K253052 - Fluoride Varnish (Type A,Type C)

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
134d slower than avg
Panel avg: 128d · 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 Consultant

Shanghai Truthful Information Technology Co., Ltd.
Boyle Wang

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 119
Devices cleared under the same product code (LBH) and FDA review panel - the closest regulatory comparables to K253052.
Profisil Free
K262243 · Kettenbach GmbH & Co. KG · Sep 2026
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UltraEZ
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K260830 · Sangi Co, Ltd. · Mar 2026
FluoroDose Varnish
K250714 · Centrix, Inc. · Nov 2025
Rennou™ Varnish (3% / Spearmint)
K243777 · Theodent, LLC · May 2025