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FDA 510(k)

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

K-Number: K223113 · 2024-04-15

ApplicantMedentika GmbH
Decision Date2024-04-15
Product CodeNHA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

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

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

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 approval number K223113.

What company makes 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 manufactured by Medentika GmbH.

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.

Related Clinical Trials

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Related PubMed Literature

PMID: 42168293 Comparative in vitro and in vivo assessment of three experimental extracellular matrix meshes for soft tissue remodeling. Scientific reports (2026)

Other Devices by Medentika GmbH

K170838Medentika CAD/CAM TiBases K180564Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM TiBases K201711CARES Screw - Retained Bars and Bridges (SRBB) K200906MINICONE Implant K191123Multi-unit Abutments K253341Custom Abutments AS

View all 8 devices →

Related Devices (Code: NHA)

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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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