FDA.report

510(k) K223395

Device
Luna Dental Implant System
Applicant
Shinhung Mst Co., Ltd.
510(k) number
K223395
Product code
NHA
Decision
Substantially Equivalent (SESE)
Decision date
2023-02-03
Date received
2022-11-08
Regulation
872.3630
Classification name
Abutment, Implant, Dental, Endosseous
Medical specialty
Dental
Review panel
Dental
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Related Records

Applicant Contact

Contact
Sun Ho Lee
Address
110-2, Donghwagongdan-Ro, Munmak-Eup Wonju-Si KR 26365 26365

FDA Registration Numbers

Source Documents

510(k) summary PDF

Related GUDID Devices

Primary DIBrandCompanyPublished
08809458311391SIS (Luna) Shinhung MST Co., Ltd.2023-02-17
08809458310912SIS (Luna) Shinhung MST Co., Ltd.2023-02-17
08806343919540SIS (Luna) Shinhung MST Co., Ltd.2023-02-17
08809458310974SIS (Luna) Shinhung MST Co., Ltd.2023-02-17
08809458310936SIS (Luna) Shinhung MST Co., Ltd.2023-02-17
08809458311056SIS (Luna) Shinhung MST Co., Ltd.2023-02-17
08809458311018SIS (Luna) Shinhung MST Co., Ltd.2023-02-17
08809458311117SIS (Luna) Shinhung MST Co., Ltd.2023-02-17
08809458311070SIS (Luna) Shinhung MST Co., Ltd.2023-02-17
08809458311216SIS (Luna) Shinhung MST Co., Ltd.2023-02-17
08809458311179SIS (Luna) Shinhung MST Co., Ltd.2023-02-17
08809458311278SIS (Luna) Shinhung MST Co., Ltd.2023-02-17
08809458311230SIS (Luna) Shinhung MST Co., Ltd.2023-02-17
08809458311353SIS (Luna) Shinhung MST Co., Ltd.2023-02-17
08809458311315SIS (Luna) Shinhung MST Co., Ltd.2023-02-17
08809458311377SIS (Luna) Shinhung MST Co., Ltd.2023-02-17
08809458311452SIS (Luna) Shinhung MST Co., Ltd.2023-02-17
08809458310899SIS (Luna) Shinhung MST Co., Ltd.2023-02-17
08809458310950SIS (Luna) Shinhung MST Co., Ltd.2023-02-17
08809458311032SIS (Luna) Shinhung MST Co., Ltd.2023-02-17
08809458311094SIS (Luna) Shinhung MST Co., Ltd.2023-02-17
08809458311193SIS (Luna) Shinhung MST Co., Ltd.2023-02-17
08809458311254SIS (Luna) Shinhung MST Co., Ltd.2023-02-17
08809458311339SIS (Luna) Shinhung MST Co., Ltd.2023-02-17
08809458311414SIS (Luna) Shinhung MST Co., Ltd.2023-02-17
08809458311438SIS (Luna) Shinhung MST Co., Ltd.2023-02-17
08809458310998SIS (Luna) Shinhung MST Co., Ltd.2023-02-17
08809458311476SIS (Luna) Shinhung MST Co., Ltd.2023-02-17
08809458311292SIS (Luna) Shinhung MST Co., Ltd.2023-02-17
08809458311131SIS (Luna) Shinhung MST Co., Ltd.2023-02-17

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