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FDA 510(k)

Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM TiBases

K-Number: K180564 · 2019-01-07

ApplicantMedentika GmbH
Decision Date2019-01-07
Product CodeNHA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM TiBases is the device name listed in this FDA 510(k) record. The listed applicant is Medentika GmbH. It received FDA 510(k) clearance on 2019-01-07 under 510(k) number K180564. The device is classified under product code NHA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

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

Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM TiBases is a medical device that received FDA 510(k) clearance on 2019-01-07. The listed applicant is Medentika GmbH. The 510(k) number is K180564.

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

Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM TiBases received FDA 510(k) clearance on 2019-01-07, under 510(k) number K180564.

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

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?

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

Other records listing Medentika GmbH as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253341Custom Abutments ASK242542Medentika CAD/CAM AbutmentsK223113Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM TiBases, Medentika Multi-unit AbutmentsK201711CARES Screw - Retained Bars and Bridges (SRBB)K200906MINICONE ImplantK191123Multi-unit Abutments

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Related Devices (Code: NHA)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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 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.K253922Neodent Scannable Healing AbutmentJJGC Indústria e Comércio de Materiais Dentários S.A.K254145Omni-Directional Multi-Unit Abutment System (Trade Name: Omnibut™)Smart Denture Conversions, LLC

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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