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.

Clearance details

Applicant: Nagy Oral Technology Qinhuangdao Co., Ltd.
Product code: 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 ↗

Recent devices under product code LBH

view all

K262243 — Profisil Free2026-09-03
K252073 — VOCO Profluorid Varnish + BioMin2026-05-01
K261404 — UltraEZ2026-04-30
K260830 — APAPRO Desensitizer Homecare (Remineralizing Anti-sensitivity Toothpaste)2026-03-18
K250714 — FluoroDose Varnish2025-11-21

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