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FDA 510(k)

IR SLA Type Implant System

K-Number: K222144 · 2023-06-14

ApplicantBiotem Co., Ltd.
Decision Date2023-06-14
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

IR SLA Type Implant System is a medical device manufactured by Biotem Co., Ltd.. It received FDA 510(k) clearance on 2023-06-14 under approval number K222144. 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 IR SLA Type Implant System?

IR SLA Type Implant System is a medical device that received FDA 510(k) clearance on 2023-06-14. It is manufactured by Biotem Co., Ltd.. The 510(k) number is K222144.

When was IR SLA Type Implant System approved by the FDA?

IR SLA Type Implant System received FDA 510(k) clearance on 2023-06-14, under approval number K222144.

What company makes IR SLA Type Implant System?

IR SLA Type Implant System is manufactured by Biotem Co., Ltd..

What is the FDA product code for IR SLA Type Implant System?

The FDA product code for IR SLA Type Implant System is DZE.

Related Clinical Trials

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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 Biotem Co., Ltd.

K171185IR Type Implant System K171179BR Type Implant System K171297AR_N Type Implant System K190641AR_N SLA Type Implant System K222142BR SLA Type 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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