Fluoride Varnish (Type A,Type C)— 510(k) K253052

Name: FDA 510(k) clearance K253052
Creator: U.S. Food and Drug Administration
Published: 2026-06-11

Substantially Equivalent

Nagy Oral Technology Qinhuangdao Co., Ltd.

FDA 510(k) clearance K253052 for Fluoride Varnish (Type A,Type C), Substantially Equivalent on 2026-06-11. Applicant: Nagy Oral Technology Qinhuangdao Co., Ltd.. Device class: 2.

Summary

Nagy Oral Technology Qinhuangdao's Fluoride Varnish comes in two types, Type A and Type C. It's filed under LBH, cavity varnishes, and the record doesn't say how the types differ.

Class II, 21 CFR 872.3260. Dental is both the classification panel and the review panel. It was a Traditional 510(k).

Nagy filed from Qinhuangdao, China. The decision came 262 calendar days after FDA received it (September 22, 2025 to June 11, 2026).

Clearance details

Applicant: Nagy Oral Technology Qinhuangdao Co., Ltd.
Product code: Product code LBH
Device class: Class 2
Regulation: 21 CFR 872.3260
Advisory panel: Dental
Date received: 2025-09-22
Decision date: 2026-06-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Qinhuangdao, CN

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.