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FDA 510(k)

OneQ-SL s-Clean Implant System

K-Number: K153639 · 2016-04-08

ApplicantDentis Co., Ltd.
Decision Date2016-04-08
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

OneQ-SL s-Clean Implant System is a medical device manufactured by Dentis Co., Ltd.. It received FDA 510(k) clearance on 2016-04-08 under approval number K153639. 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 OneQ-SL s-Clean Implant System?

OneQ-SL s-Clean Implant System is a medical device that received FDA 510(k) clearance on 2016-04-08. It is manufactured by Dentis Co., Ltd.. The 510(k) number is K153639.

When was OneQ-SL s-Clean Implant System approved by the FDA?

OneQ-SL s-Clean Implant System received FDA 510(k) clearance on 2016-04-08, under approval number K153639.

What company makes OneQ-SL s-Clean Implant System?

OneQ-SL s-Clean Implant System is manufactured by Dentis Co., Ltd..

What is the FDA product code for OneQ-SL s-Clean Implant System?

The FDA product code for OneQ-SL s-Clean 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 Dentis Co., Ltd.

K161244s-Clean OneQ-SL Narrow Implant System K160213s-Clean Tapered II RBM Implant System K171694s-Clean TiN Coating Abutments K171027Dentis Dental Implant System K170220OneQ-SL s-Clean Implant System K180657Resin for Temporary Crown & Bridge

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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