FDA.report

510(k) K233808

Device
LW Narrow Implant System
Applicant
Ossvis Co., Ltd.
510(k) number
K233808
Product code
DZE
Decision
Substantially Equivalent (SESE)
Decision date
2024-07-31
Date received
2023-11-30
Regulation
872.3640
Classification name
Implant, Endosseous, Root-Form
Medical specialty
Dental
Review panel
Dental
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Related Records

Applicant Contact

Contact
Woo Jin Lee
Address
7f And B1, 38, Burim-Ro 170beon-Gil, Dongan-Gu Anyang-Si KR 14055 14055

FDA Registration Numbers

Source Documents

510(k) summary PDF

Related GUDID Devices

Primary DIBrandCompanyPublished
08809918292048LW Narrow Vis Abutment SETOssvis Co., Ltd.2024-08-13
08809918249868LW Narrow Implant SLAOssvis Co., Ltd.2024-08-13
08809918291621LW Narrow Vis Abutment SETOssvis Co., Ltd.2024-08-13
08809918291652LW Narrow Vis Abutment SETOssvis Co., Ltd.2024-08-13
08809918291683LW Narrow Vis Abutment SETOssvis Co., Ltd.2024-08-13
08809918291713LW Narrow Vis Abutment SETOssvis Co., Ltd.2024-08-13
08809918291744LW Narrow Vis Abutment SETOssvis Co., Ltd.2024-08-13
08809918291775LW Narrow Vis Abutment SETOssvis Co., Ltd.2024-08-13
08809918291805LW Narrow Vis Abutment SETOssvis Co., Ltd.2024-08-13
08809918291836LW Narrow Vis Abutment SETOssvis Co., Ltd.2024-08-13
08809918291867LW Narrow Vis Abutment SETOssvis Co., Ltd.2024-08-13
08809918291898LW Narrow Vis Abutment SETOssvis Co., Ltd.2024-08-13
08809918291928LW Narrow Vis Abutment SETOssvis Co., Ltd.2024-08-13
08809918291959LW Narrow Vis Abutment SETOssvis Co., Ltd.2024-08-13
08809918291980LW Narrow Vis Abutment SETOssvis Co., Ltd.2024-08-13
08809918292017LW Narrow Vis Abutment SETOssvis Co., Ltd.2024-08-13
08809918292499LW Narrow Vis Abutment SETOssvis Co., Ltd.2024-08-13
08809918292079LW Narrow Vis Abutment SETOssvis Co., Ltd.2024-08-13
08809918292109LW Narrow Vis Abutment SETOssvis Co., Ltd.2024-08-13
08809918292130LW Narrow Vis Abutment SETOssvis Co., Ltd.2024-08-13
08809918292161LW Narrow Vis Abutment SETOssvis Co., Ltd.2024-08-13
08809918292192LW Narrow Vis Abutment SETOssvis Co., Ltd.2024-08-13
08809918292222LW Narrow Vis Abutment SETOssvis Co., Ltd.2024-08-13
08809918292253LW Narrow Vis Abutment SETOssvis Co., Ltd.2024-08-13
08809918292284LW Narrow Vis Abutment SETOssvis Co., Ltd.2024-08-13
08809918292314LW Narrow Vis Abutment SETOssvis Co., Ltd.2024-08-13
08809918292345LW Narrow Vis Abutment SETOssvis Co., Ltd.2024-08-13
08809918292376LW Narrow Vis Abutment SETOssvis Co., Ltd.2024-08-13
08809918292406LW Narrow Vis Abutment SETOssvis Co., Ltd.2024-08-13
08809918292437LW Narrow Vis Abutment SETOssvis Co., Ltd.2024-08-13

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