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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 a medical device manufactured by Medentika GmbH. It received FDA 510(k) clearance on 2019-01-07 under approval 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. It is manufactured by Medentika GmbH. The 510(k) number is K180564.

When was Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM TiBases approved by the FDA?

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

What company makes Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM TiBases?

Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM TiBases is manufactured by Medentika GmbH.

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.

Related Clinical Trials

NCT07246499 Multicentre Study on the Impact of Transmucosal Abutment Surface Characteristics on Peri-implant Tissues. ACTIVE_NOT_RECRUITING NCT05883202 Effect of the Abutment-Prosthesis Connection on Marginal Bone Loss and Gingival Sealing Around Dental Implants SUSPENDED

Other Devices by Medentika GmbH

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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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