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FDA 510(k)

Zeramex(R) XT Dental Implant System, NobelPearl Dental Implant System

K-Number: K180184 · 2018-11-16

ApplicantDentalpoint AG
Decision Date2018-11-16
Product CodeNHA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Zeramex(R) XT Dental Implant System, NobelPearl Dental Implant System is a medical device manufactured by Dentalpoint AG. It received FDA 510(k) clearance on 2018-11-16 under approval number K180184. 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 Zeramex(R) XT Dental Implant System, NobelPearl Dental Implant System?

Zeramex(R) XT Dental Implant System, NobelPearl Dental Implant System is a medical device that received FDA 510(k) clearance on 2018-11-16. It is manufactured by Dentalpoint AG. The 510(k) number is K180184.

When was Zeramex(R) XT Dental Implant System, NobelPearl Dental Implant System approved by the FDA?

Zeramex(R) XT Dental Implant System, NobelPearl Dental Implant System received FDA 510(k) clearance on 2018-11-16, under approval number K180184.

What company makes Zeramex(R) XT Dental Implant System, NobelPearl Dental Implant System?

Zeramex(R) XT Dental Implant System, NobelPearl Dental Implant System is manufactured by Dentalpoint AG.

What is the FDA product code for Zeramex(R) XT Dental Implant System, NobelPearl Dental Implant System?

The FDA product code for Zeramex(R) XT Dental Implant System, NobelPearl Dental Implant System is NHA.

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

K163043Zeramex P6 Dental Implant System K152385Zeramex P6 Dental Implant System

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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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