FDA 510(k)

ET Healing Abutments; ET Scan Healing Abutments; EK Scan Healing Abutments

Número K: K253372 · 2026-05-14

Data da decisão2026-05-14

Código do produtoNHA

Comité consultivoDE

DecisãoSubstantially Equivalent

Resumo do dispositivo

ET Healing Abutments; ET Scan Healing Abutments; EK Scan Healing Abutments is the device name listed in this FDA 510(k) record. The listed applicant is Hiossen, Inc.. It received FDA 510(k) clearance on 2026-05-14 under 510(k) number K253372. 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 ET Healing Abutments; ET Scan Healing Abutments; EK Scan Healing Abutments?

ET Healing Abutments; ET Scan Healing Abutments; EK Scan Healing Abutments is a medical device that received FDA 510(k) clearance on 2026-05-14. The listed applicant is Hiossen, Inc.. The 510(k) number is K253372.

When did ET Healing Abutments; ET Scan Healing Abutments; EK Scan Healing Abutments receive FDA 510(k) clearance?

ET Healing Abutments; ET Scan Healing Abutments; EK Scan Healing Abutments received FDA 510(k) clearance on 2026-05-14, under 510(k) number K253372.

Who is the listed applicant for ET Healing Abutments; ET Scan Healing Abutments; EK Scan Healing Abutments?

The FDA 510(k) record lists Hiossen, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ET Healing Abutments; ET Scan Healing Abutments; EK Scan Healing Abutments?

The FDA product code for ET Healing Abutments; ET Scan Healing Abutments; EK Scan Healing Abutments is NHA.

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Fonte oficial

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