FDA 510(k)

DD Solid Connect® CAD/CAM Abutments (further DD Ti-Base 2CUT series)

N.º K: K230218 · 2023-04-25

Fecha de decisión2023-04-25

Código de productoNHA

Comité asesorDE

DecisiónSubstantially Equivalent

Resumen del dispositivo

DD Solid Connect® CAD/CAM Abutments (further DD Ti-Base 2CUT series) is the device name listed in this FDA 510(k) record. The listed applicant is Dental Direkt GmbH. It received FDA 510(k) clearance on 2023-04-25 under 510(k) number K230218. 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 DD Solid Connect® CAD/CAM Abutments (further DD Ti-Base 2CUT series)?

DD Solid Connect® CAD/CAM Abutments (further DD Ti-Base 2CUT series) is a medical device that received FDA 510(k) clearance on 2023-04-25. The listed applicant is Dental Direkt GmbH. The 510(k) number is K230218.

When did DD Solid Connect® CAD/CAM Abutments (further DD Ti-Base 2CUT series) receive FDA 510(k) clearance?

DD Solid Connect® CAD/CAM Abutments (further DD Ti-Base 2CUT series) received FDA 510(k) clearance on 2023-04-25, under 510(k) number K230218.

Who is the listed applicant for DD Solid Connect® CAD/CAM Abutments (further DD Ti-Base 2CUT series)?

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

What is the FDA product code for DD Solid Connect® CAD/CAM Abutments (further DD Ti-Base 2CUT series)?

The FDA product code for DD Solid Connect® CAD/CAM Abutments (further DD Ti-Base 2CUT series) is NHA.

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Otros registros que enlistan a Dental Direkt GmbH como solicitante

K241579DD Hybridlayer (multicolored zirconia)K230410DD medical polymers (PMMA)K191111DD Solid Connect® CAD/CAM Abutments K193588DD Contrast K183569DD cube ONE ML K170885DD cubeX2 HS

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Dispositivos relacionados (Código: NHA)

K262207Cemented Plus AbutmentUnidental Co., Ltd.K260940BellaTek BarsZimVie US Corp, LLC K253999Universal 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 AB K261147Neodent Implant System - NeoConvert FitJJGC Indústria e Comércio de Materiais Dentários S.A.K261122MIST ICImagine Milling Technologies, LLC K260061BioHorizons 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.