FDA 510(k)

Fluoride Varnish (Type A,Type C)

N.º K: K253052 · 2026-06-11

SolicitanteNagy Oral Technology Qinhuangdao Co., Ltd.

Fecha de decisión2026-06-11

Código de productoLBH

Comité asesorDE

DecisiónSubstantially Equivalent

Resumen del dispositivo

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.

Preguntas frecuentes

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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Dispositivos relacionados (Código: LBH)

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Fuente oficial

Ver en la base de datos de la FDA →

Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.