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FDA 510(k)

Z7 Zirconia Implant System

K-Number: K221488 · 2023-06-26

ApplicantZ7, LLC
Decision Date2023-06-26
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Z7 Zirconia Implant System is a medical device manufactured by Z7, LLC. It received FDA 510(k) clearance on 2023-06-26 under approval number K221488. 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 Z7 Zirconia Implant System?

Z7 Zirconia Implant System is a medical device that received FDA 510(k) clearance on 2023-06-26. It is manufactured by Z7, LLC. The 510(k) number is K221488.

When was Z7 Zirconia Implant System approved by the FDA?

Z7 Zirconia Implant System received FDA 510(k) clearance on 2023-06-26, under approval number K221488.

What company makes Z7 Zirconia Implant System?

Z7 Zirconia Implant System is manufactured by Z7, LLC.

What is the FDA product code for Z7 Zirconia Implant System?

The FDA product code for Z7 Zirconia Implant System is DZE.

Related Clinical Trials

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Related PubMed Literature

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)

Related Devices (Code: DZE)

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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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