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FDA 510(k)

OSSTEM Implant System

K-Number: K161604 · 2016-10-17

ApplicantOsstem Implant Co., Ltd.
Decision Date2016-10-17
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

OSSTEM Implant System is a medical device manufactured by Osstem Implant Co., Ltd.. It received FDA 510(k) clearance on 2016-10-17 under approval number K161604. 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 OSSTEM Implant System?

OSSTEM Implant System is a medical device that received FDA 510(k) clearance on 2016-10-17. It is manufactured by Osstem Implant Co., Ltd.. The 510(k) number is K161604.

When was OSSTEM Implant System approved by the FDA?

OSSTEM Implant System received FDA 510(k) clearance on 2016-10-17, under approval number K161604.

What company makes OSSTEM Implant System?

OSSTEM Implant System is manufactured by Osstem Implant Co., Ltd..

What is the FDA product code for OSSTEM Implant System?

The FDA product code for OSSTEM 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)

Other Devices by Osstem Implant Co., Ltd.

K161197Orthodontic Screw K153015Transfer & Angled Abutment K160519Link Abutment for CEREC K170736HySil Impression Materials K161689OSSTEM Implant System - Abutment K163557SS SA Fixture

View all 31 devices →

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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