FDA 510(k) Applications Submitted by Dentis Co., Ltd.

FDA 510(k) Number Submission Date Device Name Applicant
K111364 05/16/2011 HAPTITE COATING IMPLANT SYSTEM DENTIS CO., LTD.
K180657 03/13/2018 Resin for Temporary Crown & Bridge Dentis Co., Ltd.
K230203 01/25/2023 Dentis I-FIX Abutment Dentis Co., Ltd.
K230246 01/30/2023 Dentis s-Clean SQ-SL Narrow Implant System Dentis Co., Ltd.
K200099 01/16/2020 s-Clean SQ-SL Implant System Mini Dentis Co., Ltd.
K230307 02/03/2023 Dentis i-Clean System Dentis Co., Ltd.
K222913 09/26/2022 s-Clean Link Abutment Dentis Co., Ltd.
K210080 01/12/2021 Dentis s-Clean s-Line Mini Dentis Co., Ltd.
K210132 01/19/2021 s-Clean SQ-SL Implant System Regular Dentis Co., Ltd.
K210134 01/19/2021 Dentis s-Clean s-Line Dentis Co., Ltd.
K210362 02/08/2021 s-Clean Pre-Milled Abutment Dentis Co., Ltd.
K210410 02/11/2021 s-Clean Pre-Milled Abutment Mini Dentis Co., Ltd.
K220440 02/16/2022 Dentis s-Clean Abutment Mini Dentis Co., Ltd.
K230523 02/27/2023 s-Clean Link Abutment Narrow Dentis Co., Ltd.
K222367 08/05/2022 SAVE GBR Dentis Co., Ltd.
K222451 08/15/2022 SAVE GBR Dentis Co., Ltd.
K202773 09/21/2020 s-Clean SQ-SL Implant System Mini Dentis Co., Ltd.
K192688 09/26/2019 s-Clean SQ-SL Implant System Regular Dentis Co., Ltd.
K150344 02/11/2015 Dentis Dental Implant System DENTIS CO., LTD.
K170220 01/25/2017 OneQ-SL s-Clean Implant System DENTIS CO., LTD.
K160213 01/29/2016 s-Clean Tapered II RBM Implant System Dentis Co., Ltd.
K161244 05/03/2016 s-Clean OneQ-SL Narrow Implant System Dentis Co., Ltd.
K171694 06/07/2017 s-Clean TiN Coating Abutments Dentis Co., Ltd.
K153639 12/21/2015 OneQ-SL s-Clean Implant System DENTIS CO., LTD.


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