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FDA 510(k)

IU Implant System Abutment

K-Number: K221969 · 2023-05-12

ApplicantWarantec Co., Ltd.
Decision Date2023-05-12
Product CodeNHA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

IU Implant System Abutment is a medical device manufactured by Warantec Co., Ltd.. It received FDA 510(k) clearance on 2023-05-12 under approval number K221969. 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 IU Implant System Abutment?

IU Implant System Abutment is a medical device that received FDA 510(k) clearance on 2023-05-12. It is manufactured by Warantec Co., Ltd.. The 510(k) number is K221969.

When was IU Implant System Abutment approved by the FDA?

IU Implant System Abutment received FDA 510(k) clearance on 2023-05-12, under approval number K221969.

What company makes IU Implant System Abutment?

IU Implant System Abutment is manufactured by Warantec Co., Ltd..

What is the FDA product code for IU Implant System Abutment?

The FDA product code for IU 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 Warantec Co., Ltd.

K172345IU Implant System K221972Warantec Custom Abutment

Related Devices (Code: NHA)

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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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