FDA 510(k)

Guided Bone Regeneration System

Número K: K254286 · 2026-08-24

RequerenteDentalMaster(Xiamen)Medical Technology Co., Ltd.

Data da decisão2026-08-24

Código do produtoDZL

Comité consultivoDE

DecisãoSubstantially Equivalent

Resumo do dispositivo

Guided Bone Regeneration System is the device name listed in this FDA 510(k) record. The listed applicant is DentalMaster(Xiamen)Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2026-08-24 under 510(k) number K254286. The device is classified under product code DZL. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Guided Bone Regeneration System?

Guided Bone Regeneration System is a medical device that received FDA 510(k) clearance on 2026-08-24. The listed applicant is DentalMaster(Xiamen)Medical Technology Co., Ltd.. The 510(k) number is K254286.

When did Guided Bone Regeneration System receive FDA 510(k) clearance?

Guided Bone Regeneration System received FDA 510(k) clearance on 2026-08-24, under 510(k) number K254286.

Who is the listed applicant for Guided Bone Regeneration System?

O registro FDA 510(k) lista DentalMaster(Xiamen)Medical Technology Co., Ltd. como o solicitante. Isso por si só não estabelece o fabricante do dispositivo.

What is the FDA product code for Guided Bone Regeneration System?

The FDA product code for Guided Bone Regeneration System is DZL.

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Fonte oficial

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