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FDA 510(k)

Zeramex P6 Dental Implant System

K-Number: K163043 · 2016-11-30

ApplicantDentalpoint AG
Decision Date2016-11-30
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Zeramex P6 Dental Implant System is a medical device manufactured by Dentalpoint AG. It received FDA 510(k) clearance on 2016-11-30 under approval number K163043. The device is classified under product code DZE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Zeramex P6 Dental Implant System?

Zeramex P6 Dental Implant System is a medical device that received FDA 510(k) clearance on 2016-11-30. It is manufactured by Dentalpoint AG. The 510(k) number is K163043.

When was Zeramex P6 Dental Implant System approved by the FDA?

Zeramex P6 Dental Implant System received FDA 510(k) clearance on 2016-11-30, under approval number K163043.

What company makes Zeramex P6 Dental Implant System?

Zeramex P6 Dental Implant System is manufactured by Dentalpoint AG.

What is the FDA product code for Zeramex P6 Dental Implant System?

The FDA product code for Zeramex P6 Dental Implant System is DZE.

Related Clinical Trials

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Related PubMed Literature

PMID: 39892748 Long-term Safety and Performance of a Suprachoroidal Pressure Sensor System: Results of the EYEMATE-SC Trial Follow-up Study. Ophthalmology (2025) PMID: 41966145 From Registry to Reality: Opportunities to Enhance Post-market Surveillance of High-Risk Medical Devices Comment on "Quality and Utility of European Cardiovascular and Orthopaedic Registries for the Regulatory Evaluation of Medical Device Safety and Performance Across the Implant Lifecycle: A Systematic Review". International journal of health policy and management (2025) PMID: 39726899 How to improve the mechanical safety of a novel spinal implant while saving costs and time. JOR spine (2024)

Other Devices by Dentalpoint AG

K152385Zeramex P6 Dental Implant System K180184Zeramex(R) XT Dental Implant System, NobelPearl Dental Implant System

Related Devices (Code: DZE)

K160475Ritter Dental Implant SystemRitter Implants GmbH & Co. KG K161244s-Clean OneQ-SL Narrow Implant SystemDentis Co., Ltd. K161497Dental Implants and AbutmentsDitron Precision, Ltd. K153332ETIII SA Fixture System (O3.2mm)Hiossen, Inc. K151970KJ Mini Implant SystemKj Meditech Co., Ltd. K161604OSSTEM Implant SystemOsstem Implant Co., Ltd.

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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