FDA 510(k)

MIS LOCKiT Abutments System, OT-Equators and Ball Attachments

N.º K: K182228 · 2019-01-28

SolicitanteMis Implants Technologies , Ltd.

Fecha de decisión2019-01-28

Código de productoNHA

Comité asesorDE

DecisiónSubstantially Equivalent

Resumen del dispositivo

MIS LOCKiT Abutments System, OT-Equators and Ball Attachments is the device name listed in this FDA 510(k) record. The listed applicant is Mis Implants Technologies , Ltd.. It received FDA 510(k) clearance on 2019-01-28 under 510(k) number K182228. 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 MIS LOCKiT Abutments System, OT-Equators and Ball Attachments?

MIS LOCKiT Abutments System, OT-Equators and Ball Attachments is a medical device that received FDA 510(k) clearance on 2019-01-28. The listed applicant is Mis Implants Technologies , Ltd.. The 510(k) number is K182228.

When did MIS LOCKiT Abutments System, OT-Equators and Ball Attachments receive FDA 510(k) clearance?

MIS LOCKiT Abutments System, OT-Equators and Ball Attachments received FDA 510(k) clearance on 2019-01-28, under 510(k) number K182228.

Who is the listed applicant for MIS LOCKiT Abutments System, OT-Equators and Ball Attachments?

The FDA 510(k) record lists Mis Implants Technologies , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MIS LOCKiT Abutments System, OT-Equators and Ball Attachments?

The FDA product code for MIS LOCKiT Abutments System, OT-Equators and Ball Attachments is NHA.

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Otros registros que enlistan a Mis Implants Technologies , Ltd. como solicitante

K180282MIS Internal Hex Dental Implant System K173326MIS CONNECT Conical Connection Abutment K172505MIS C1 Narrow Platform Conical Connection Implant System, MIS C1 Wide Platform Conical Connection Abutments K163349MIS V3 Conical Connection Dental Implant System

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.