FDA 510(k)

SmartShape™ Healing Abutment; Wide Custom Milled Ti-Blank Abutment

N.º K: K240531 · 2024-07-30

SolicitanteBioHorizons Implant Systems, Inc.

Fecha de decisión2024-07-30

Código de productoNHA

Comité asesorDE

DecisiónSubstantially Equivalent

Resumen del dispositivo

SmartShape™ Healing Abutment; Wide Custom Milled Ti-Blank Abutment is the device name listed in this FDA 510(k) record. The listed applicant is BioHorizons Implant Systems, Inc.. It received FDA 510(k) clearance on 2024-07-30 under 510(k) number K240531. 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 SmartShape™ Healing Abutment; Wide Custom Milled Ti-Blank Abutment?

SmartShape™ Healing Abutment; Wide Custom Milled Ti-Blank Abutment is a medical device that received FDA 510(k) clearance on 2024-07-30. The listed applicant is BioHorizons Implant Systems, Inc.. The 510(k) number is K240531.

When did SmartShape™ Healing Abutment; Wide Custom Milled Ti-Blank Abutment receive FDA 510(k) clearance?

SmartShape™ Healing Abutment; Wide Custom Milled Ti-Blank Abutment received FDA 510(k) clearance on 2024-07-30, under 510(k) number K240531.

Who is the listed applicant for SmartShape™ Healing Abutment; Wide Custom Milled Ti-Blank Abutment?

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

What is the FDA product code for SmartShape™ Healing Abutment; Wide Custom Milled Ti-Blank Abutment?

The FDA product code for SmartShape™ Healing Abutment; Wide Custom Milled Ti-Blank Abutment is NHA.

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Otros registros que enlistan a BioHorizons Implant Systems, Inc. como solicitante

K260061BioHorizons CEREC Compatible Ti-Bases K243521Conical Ti Base abutments K240187Tapered Pro Conical Implant System K223697MRI compatibility for existing BioHorizons dental implants and abutments K203252Multi-unit Abutments for CONELOG K182070BioHorizons Tapered IM Implants

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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 →

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