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FDA 510(k)

s-Clean SQ-SL Implant System Regular

K-Number: K210132 · 2021-02-17

ApplicantDentis Co., Ltd.
Decision Date2021-02-17
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

s-Clean SQ-SL Implant System Regular is a medical device manufactured by Dentis Co., Ltd.. It received FDA 510(k) clearance on 2021-02-17 under approval number K210132. 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 s-Clean SQ-SL Implant System Regular?

s-Clean SQ-SL Implant System Regular is a medical device that received FDA 510(k) clearance on 2021-02-17. It is manufactured by Dentis Co., Ltd.. The 510(k) number is K210132.

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

s-Clean SQ-SL Implant System Regular received FDA 510(k) clearance on 2021-02-17, under approval number K210132.

What company makes s-Clean SQ-SL Implant System Regular?

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

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

The FDA product code for s-Clean SQ-SL Implant System Regular is DZE.

Related Clinical Trials

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Related PubMed Literature

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)

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 →

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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