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FDA 510(k)

SD TL Implant System

K-Number: K250280 · 2025-07-23

ApplicantArum Dentistry Co., Ltd.
Decision Date2025-07-23
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SD TL Implant System is a medical device manufactured by Arum Dentistry Co., Ltd.. It received FDA 510(k) clearance on 2025-07-23 under approval number K250280. 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 SD TL Implant System?

SD TL Implant System is a medical device that received FDA 510(k) clearance on 2025-07-23. It is manufactured by Arum Dentistry Co., Ltd.. The 510(k) number is K250280.

When was SD TL Implant System approved by the FDA?

SD TL Implant System received FDA 510(k) clearance on 2025-07-23, under approval number K250280.

What company makes SD TL Implant System?

SD TL Implant System is manufactured by Arum Dentistry Co., Ltd..

What is the FDA product code for SD TL Implant System?

The FDA product code for SD TL 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 Arum Dentistry Co., Ltd.

K193425Pre-Milled Blank K210817C&B 5.0 Hybrid K222131NB 1 SA Implant System K213506NB 1 SA Implant System K232560Angled Abutment K230725NB Implant System

View all 17 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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