FDA 510(k)

ISO Abutment

Número K: K241183 · 2025-07-28

Data da decisão2025-07-28

Código do produtoNHA

Comité consultivoDE

DecisãoSubstantially Equivalent

Resumo do dispositivo

ISO Abutment is the device name listed in this FDA 510(k) record. The listed applicant is Seum Medi Co., Ltd.. It received FDA 510(k) clearance on 2025-07-28 under 510(k) number K241183. The device is classified under product code NHA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the ISO Abutment?

ISO Abutment is a medical device that received FDA 510(k) clearance on 2025-07-28. The listed applicant is Seum Medi Co., Ltd.. The 510(k) number is K241183.

When did ISO Abutment receive FDA 510(k) clearance?

ISO Abutment received FDA 510(k) clearance on 2025-07-28, under 510(k) number K241183.

Who is the listed applicant for ISO Abutment?

The FDA 510(k) record lists Seum Medi Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ISO Abutment?

The FDA product code for ISO Abutment is NHA.

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Fonte oficial

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