FDA 510(k)

Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM TiBases, Medentika Multi-unit Abutments

Número K: K223113 · 2024-04-15

Data da decisão2024-04-15

Código do produtoNHA

Comité consultivoDE

DecisãoSubstantially Equivalent

Resumo do dispositivo

Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM TiBases, Medentika Multi-unit Abutments is the device name listed in this FDA 510(k) record. The listed applicant is Medentika GmbH. It received FDA 510(k) clearance on 2024-04-15 under 510(k) number K223113. The device is classified under product code NHA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM TiBases, Medentika Multi-unit Abutments?

Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM TiBases, Medentika Multi-unit Abutments is a medical device that received FDA 510(k) clearance on 2024-04-15. The listed applicant is Medentika GmbH. The 510(k) number is K223113.

When did Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM TiBases, Medentika Multi-unit Abutments receive FDA 510(k) clearance?

Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM TiBases, Medentika Multi-unit Abutments received FDA 510(k) clearance on 2024-04-15, under 510(k) number K223113.

Who is the listed applicant for Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM TiBases, Medentika Multi-unit Abutments?

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

What is the FDA product code for Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM TiBases, Medentika Multi-unit Abutments?

The FDA product code for Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM TiBases, Medentika Multi-unit Abutments is NHA.

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Outros registros que listam Medentika GmbH como candidato(a)

K253341Custom Abutments AS K242542Medentika CAD/CAM Abutments K201711CARES Screw - Retained Bars and Bridges (SRBB)K200906MINICONE Implant K191123Multi-unit Abutments K180564Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM TiBases

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Fonte oficial

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