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FDA 510(k)

Dentis s-Clean SQ-SL Narrow Implant System

K-Number: K230246 · 2023-05-25

ApplicantDentis Co., Ltd.
Decision Date2023-05-25
Product CodeNHA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Dentis s-Clean SQ-SL Narrow Implant System is a medical device manufactured by Dentis Co., Ltd.. It received FDA 510(k) clearance on 2023-05-25 under approval number K230246. 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 Dentis s-Clean SQ-SL Narrow Implant System?

Dentis s-Clean SQ-SL Narrow Implant System is a medical device that received FDA 510(k) clearance on 2023-05-25. It is manufactured by Dentis Co., Ltd.. The 510(k) number is K230246.

When was Dentis s-Clean SQ-SL Narrow Implant System approved by the FDA?

Dentis s-Clean SQ-SL Narrow Implant System received FDA 510(k) clearance on 2023-05-25, under approval number K230246.

What company makes Dentis s-Clean SQ-SL Narrow Implant System?

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

What is the FDA product code for Dentis s-Clean SQ-SL Narrow Implant System?

The FDA product code for Dentis s-Clean SQ-SL Narrow Implant System is NHA.

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 Dentis Co., Ltd.

K161244s-Clean OneQ-SL Narrow Implant System K160213s-Clean Tapered II RBM Implant System K153639OneQ-SL s-Clean Implant System K171694s-Clean TiN Coating Abutments K171027Dentis Dental Implant System K170220OneQ-SL s-Clean Implant System

View all 31 devices →

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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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