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FDA 510(k)

4plus6Line Abutment System

N.º K: K151608 · 2016-04-13

SolicitanteOt Medical GmbH
Fecha de decisión2016-04-13
Código de productoNHA
Comité asesorDE
DecisiónSubstantially Equivalent

Resumen del dispositivo

4plus6Line Abutment System is the device name listed in this FDA 510(k) record. The listed applicant is Ot Medical GmbH. It received FDA 510(k) clearance on 2016-04-13 under 510(k) number K151608. 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 4plus6Line Abutment System?

4plus6Line Abutment System is a medical device that received FDA 510(k) clearance on 2016-04-13. The listed applicant is Ot Medical GmbH. The 510(k) number is K151608.

When did 4plus6Line Abutment System receive FDA 510(k) clearance?

4plus6Line Abutment System received FDA 510(k) clearance on 2016-04-13, under 510(k) number K151608.

Who is the listed applicant for 4plus6Line Abutment System?

The FDA 510(k) record lists Ot Medical GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 4plus6Line Abutment System?

The FDA product code for 4plus6Line Abutment System is NHA.

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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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