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FDA 510(k)

OSSTEM Implant System - Abutment

K-Number: K161689 · 2017-05-22

ApplicantOsstem Implant Co., Ltd.
Decision Date2017-05-22
Product CodeNHA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

OSSTEM Implant System - Abutment is a medical device manufactured by Osstem Implant Co., Ltd.. It received FDA 510(k) clearance on 2017-05-22 under approval number K161689. 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 OSSTEM Implant System - Abutment?

OSSTEM Implant System - Abutment is a medical device that received FDA 510(k) clearance on 2017-05-22. It is manufactured by Osstem Implant Co., Ltd.. The 510(k) number is K161689.

When was OSSTEM Implant System - Abutment approved by the FDA?

OSSTEM Implant System - Abutment received FDA 510(k) clearance on 2017-05-22, under approval number K161689.

What company makes OSSTEM Implant System - Abutment?

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

What is the FDA product code for OSSTEM Implant System - Abutment?

The FDA product code for OSSTEM Implant System - Abutment is NHA.

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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 Osstem Implant Co., Ltd.

K161197Orthodontic Screw K153015Transfer & Angled Abutment K160519Link Abutment for CEREC K161604OSSTEM Implant System K170736HySil Impression Materials K163557SS SA Fixture

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Related Devices (Code: NHA)

K161713Dentium CAD/CAM AbutmentsDentium Co., Ltd. K160798IPS e.max® Press Abutment Solutions for Viteo Base TiIvoclar Vivadent, AG K162004PREMIUM Implant Systems SHELTA Implant SystemsSweden & Martina S.P.A. K153015Transfer & Angled AbutmentOsstem Implant Co., Ltd. K161435Temporary Snap AbutmentNobel Biocare AB K160786RODO Abutment SystemRodo Medical, Inc.

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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