FDA 510(k)

Flowable Restorative Material (KP-Flow LF, KP-Flow MF, KP-Flow HF)

Número K: K261695 · 2026-08-31

RequerenteGuilin Kevin Peter Technology Co., Ltd.

Data da decisão2026-08-31

Código do produtoEBF

Comité consultivoDE

DecisãoSubstantially Equivalent

Resumo do dispositivo

Flowable Restorative Material (KP-Flow LF, KP-Flow MF, KP-Flow HF) is the device name listed in this FDA 510(k) record. The listed applicant is Guilin Kevin Peter Technology Co., Ltd.. It received FDA 510(k) clearance on 2026-08-31 under 510(k) number K261695. The device is classified under product code EBF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Flowable Restorative Material (KP-Flow LF, KP-Flow MF, KP-Flow HF)?

Flowable Restorative Material (KP-Flow LF, KP-Flow MF, KP-Flow HF) is a medical device that received FDA 510(k) clearance on 2026-08-31. The listed applicant is Guilin Kevin Peter Technology Co., Ltd.. The 510(k) number is K261695.

When did Flowable Restorative Material (KP-Flow LF, KP-Flow MF, KP-Flow HF) receive FDA 510(k) clearance?

Flowable Restorative Material (KP-Flow LF, KP-Flow MF, KP-Flow HF) received FDA 510(k) clearance on 2026-08-31, under 510(k) number K261695.

Who is the listed applicant for Flowable Restorative Material (KP-Flow LF, KP-Flow MF, KP-Flow HF)?

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

What is the FDA product code for Flowable Restorative Material (KP-Flow LF, KP-Flow MF, KP-Flow HF)?

The FDA product code for Flowable Restorative Material (KP-Flow LF, KP-Flow MF, KP-Flow HF) is EBF.

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Outros registros que listam Guilin Kevin Peter Technology Co., Ltd. como candidato(a)

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Fonte oficial

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