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FDA 510(k)

OsteoReady Dental Implant System

K-Number: K173575 · 2018-08-17

ApplicantOsteoready, LLC
Decision Date2018-08-17
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

OsteoReady Dental Implant System is a medical device manufactured by Osteoready, LLC. It received FDA 510(k) clearance on 2018-08-17 under approval number K173575. 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 OsteoReady Dental Implant System?

OsteoReady Dental Implant System is a medical device that received FDA 510(k) clearance on 2018-08-17. It is manufactured by Osteoready, LLC. The 510(k) number is K173575.

When was OsteoReady Dental Implant System approved by the FDA?

OsteoReady Dental Implant System received FDA 510(k) clearance on 2018-08-17, under approval number K173575.

What company makes OsteoReady Dental Implant System?

OsteoReady Dental Implant System is manufactured by Osteoready, LLC.

What is the FDA product code for OsteoReady Dental Implant System?

The FDA product code for OsteoReady Dental Implant System is DZE.

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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)

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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