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FDA 510(k)

Fluoride Varnish (Type A,Type C)

K-Number: K253052 · 2026-06-11

ApplicantNagy Oral Technology Qinhuangdao Co., Ltd.
Decision Date2026-06-11
Product CodeLBH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Fluoride Varnish (Type A,Type C) is the device name listed in this FDA 510(k) record. The listed applicant is Nagy Oral Technology Qinhuangdao Co., Ltd.. It received FDA 510(k) clearance on 2026-06-11 under 510(k) number K253052. The device is classified under product code LBH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Fluoride Varnish (Type A,Type C)?

Fluoride Varnish (Type A,Type C) is a medical device that received FDA 510(k) clearance on 2026-06-11. The listed applicant is Nagy Oral Technology Qinhuangdao Co., Ltd.. The 510(k) number is K253052.

When did Fluoride Varnish (Type A,Type C) receive FDA 510(k) clearance?

Fluoride Varnish (Type A,Type C) received FDA 510(k) clearance on 2026-06-11, under 510(k) number K253052.

Who is the listed applicant for Fluoride Varnish (Type A,Type C)?

The FDA 510(k) record lists Nagy Oral Technology Qinhuangdao Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Fluoride Varnish (Type A,Type C)?

The FDA product code for Fluoride Varnish (Type A,Type C) is LBH.

Related Devices (Code: LBH)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252073VOCO Profluorid Varnish + BioMinVoco GmbHK261404UltraEZUltradent Products, Inc.K260830APAPRO Desensitizer Homecare (Remineralizing Anti-sensitivity Toothpaste)Sangi Co., Ltd.K250714FluoroDose VarnishCentrix, Inc.K243777Rennou™ Varnish (3% / Spearmint); Rennou™ Varnish (3% / Strawberry); Rennou™ Varnish (3% / Cherry); Rennou™ Varnish (3% / Bubble Gum)Theodent, LLCK241489ReminGelInter-Med, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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