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FDA 510(k)

OsseOne Dental Implant System

K-Number: K182293 · 2019-02-15

ApplicantSynoross Dba Osseone
Decision Date2019-02-15
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

OsseOne Dental Implant System is a medical device manufactured by Synoross Dba Osseone. It received FDA 510(k) clearance on 2019-02-15 under approval number K182293. 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 OsseOne Dental Implant System?

OsseOne Dental Implant System is a medical device that received FDA 510(k) clearance on 2019-02-15. It is manufactured by Synoross Dba Osseone. The 510(k) number is K182293.

When was OsseOne Dental Implant System approved by the FDA?

OsseOne Dental Implant System received FDA 510(k) clearance on 2019-02-15, under approval number K182293.

What company makes OsseOne Dental Implant System?

OsseOne Dental Implant System is manufactured by Synoross Dba Osseone.

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

The FDA product code for OsseOne 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)

Other Devices by Synoross Dba Osseone

K233271OsseOne Dental Implant System

Related Devices (Code: DZE)

K160475Ritter Dental Implant SystemRitter Implants GmbH & Co. KG K161244s-Clean OneQ-SL Narrow Implant SystemDentis Co., Ltd. K163043Zeramex P6 Dental Implant SystemDentalpoint AG K161497Dental Implants and AbutmentsDitron Precision, Ltd. K153332ETIII SA Fixture System (O3.2mm)Hiossen, Inc. K151970KJ Mini Implant SystemKj Meditech 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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