FDA 510(k)

Fluoride Varnish (Type A,Type C)

K-Nummer: K253052 · 2026-06-11

AntragstellerNagy Oral Technology Qinhuangdao Co., Ltd.

Entscheidungsdatum2026-06-11

ProduktcodeLBH

BeratungsausschussDE

EntscheidungSubstantially Equivalent

Produktübersicht

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.

Häufig gestellte Fragen

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.

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Verwandte Geräte (Code: LBH)

K262243Profisil FreeKettenbach GmbH & Co. KG K252073VOCO Profluorid Varnish + BioMinVoco GmbH K261404UltraEZUltradent Products, Inc.K260830APAPRO Desensitizer Homecare (Remineralisierende Anti-Sensitivität Zahnpasta)Sangi Co., Ltd.K250714FluoroDose VarnishCentrix, Inc.K243777Rennou™ Varnish (3% / Spearmint); Rennou™ Varnish (3% / Strawberry); Rennou™ Varnish (3% / Cherry); Rennou™ Varnish (3% / Bubble Gum)Theodent, LLC

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