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FDA 510(k)

HIOSSEN Pre-milled Abutment (ET Pre-milled Abutment & EK Pre-milled Abutment)

N.º K: K241003 · 2025-01-08

SolicitanteHiossen, Inc.
Fecha de decisión2025-01-08
Código de productoNHA
Comité asesorDE
DecisiónSubstantially Equivalent

Resumen del dispositivo

HIOSSEN Pre-milled Abutment (ET Pre-milled Abutment & EK Pre-milled Abutment) is the device name listed in this FDA 510(k) record. The listed applicant is Hiossen, Inc.. It received FDA 510(k) clearance on 2025-01-08 under 510(k) number K241003. The device is classified under product code NHA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the HIOSSEN Pre-milled Abutment (ET Pre-milled Abutment & EK Pre-milled Abutment)?

HIOSSEN Pre-milled Abutment (ET Pre-milled Abutment & EK Pre-milled Abutment) is a medical device that received FDA 510(k) clearance on 2025-01-08. The listed applicant is Hiossen, Inc.. The 510(k) number is K241003.

When did HIOSSEN Pre-milled Abutment (ET Pre-milled Abutment & EK Pre-milled Abutment) receive FDA 510(k) clearance?

HIOSSEN Pre-milled Abutment (ET Pre-milled Abutment & EK Pre-milled Abutment) received FDA 510(k) clearance on 2025-01-08, under 510(k) number K241003.

Who is the listed applicant for HIOSSEN Pre-milled Abutment (ET Pre-milled Abutment & EK Pre-milled Abutment)?

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 HIOSSEN Pre-milled Abutment (ET Pre-milled Abutment & EK Pre-milled Abutment)?

The FDA product code for HIOSSEN Pre-milled Abutment (ET Pre-milled Abutment & EK Pre-milled Abutment) is NHA.

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Otros registros que enlistan a Hiossen, Inc. como solicitante

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K253372ET Healing Abutments; ET Scan Healing Abutments; EK Scan Healing AbutmentsK251427EK MULTI ANGLED 30 ABUTMENTK240232EK D3.3 and Ultra Wide ImplantsK233389EK Digital AbutmentsK222636ET Abutment SystemK203360EK Implants and Abutments System

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Dispositivos relacionados (Código: NHA)

Los registros relacionados se emparejan automáticamente mediante nombres, códigos de producto u otros metadatos. Un emparejamiento no establece una relación clínica, científica, corporativa o regulatoria verificada; revise las fuentes oficiales enlazadas.

K262207Cemented Plus AbutmentUnidental Co., Ltd.K260940BellaTek BarsZimVie US Corp, LLCK253999Universal Base ASC Engaging; Universal Base ASC Non-Engaging; Universal Base MUA ASC; Temporary Abutment Engaging and Non-Engaging; Healing Abutment Conical Connection; Omnigrip Clinical Screw Titanium; Omnigrip Prosthetic ScrewNobel Biocare ABK261147Neodent Implant System - NeoConvert FitJJGC Indústria e Comércio de Materiais Dentários S.A.K261122MIST ICImagine Milling Technologies, LLCK260061BioHorizons CEREC Compatible Ti-BasesBioHorizons Implant Systems, Inc.

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.

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