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FDA 510(k)

Medentika CAD/CAM TiBases

K-Number: K170838 · 2017-09-15

ApplicantMedentika GmbH
Decision Date2017-09-15
Product CodeNHA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

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 2017-09-15 under 510(k) number K170838. 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 CAD/CAM TiBases?

Medentika CAD/CAM TiBases is a medical device that received FDA 510(k) clearance on 2017-09-15. The listed applicant is Medentika GmbH. The 510(k) number is K170838.

When did Medentika CAD/CAM TiBases receive FDA 510(k) clearance?

Medentika CAD/CAM TiBases received FDA 510(k) clearance on 2017-09-15, under 510(k) number K170838.

Who is the listed applicant for 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 CAD/CAM TiBases?

The FDA product code for 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

View all 8 devices →

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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