FDA.report

510(k) K230523

Device
s-Clean Link Abutment Narrow
Applicant
Dentis Co., Ltd.
510(k) number
K230523
Product code
NHA
Decision
Substantially Equivalent (SESE)
Decision date
2023-05-24
Date received
2023-02-27
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
Gyu Ri Kim
Address
99, Seongseoseo-Ro Dalseo-Gu Daegu KR 42718 42718

FDA Registration Numbers

Source Documents

510(k) summary PDF

Related GUDID Devices

Primary DIBrandCompanyPublished
08800053042390s-Clean Link Abutment NarrowDENTIS CO. ,LTD2023-05-30
08800053038577s-Clean Link Abutment NarrowDENTIS CO. ,LTD2023-05-30
08800053038584s-Clean Link Abutment NarrowDENTIS CO. ,LTD2023-05-30
08800053038591s-Clean Link Abutment NarrowDENTIS CO. ,LTD2023-05-30
08800053038607s-Clean Link Abutment NarrowDENTIS CO. ,LTD2023-05-30
08800053038614s-Clean Link Abutment NarrowDENTIS CO. ,LTD2023-05-30
08800053038621s-Clean Link Abutment NarrowDENTIS CO. ,LTD2023-05-30
08800053038638s-Clean Link Abutment NarrowDENTIS CO. ,LTD2023-05-30
08800053038645s-Clean Link Abutment NarrowDENTIS CO. ,LTD2023-05-30
08800053038652s-Clean Link Abutment NarrowDENTIS CO. ,LTD2023-05-30
08800053038669s-Clean Link Abutment NarrowDENTIS CO. ,LTD2023-05-30
08800053038676s-Clean Link Abutment NarrowDENTIS CO. ,LTD2023-05-30
08800053038683s-Clean Link Abutment NarrowDENTIS CO. ,LTD2023-05-30
08800053042260s-Clean Link Abutment NarrowDENTIS CO. ,LTD2023-05-30
08800053042277s-Clean Link Abutment NarrowDENTIS CO. ,LTD2023-05-30
08800053042383s-Clean Link Abutment NarrowDENTIS CO. ,LTD2023-05-30
08800053043250s-Clean Link Abutment NarrowDENTIS CO. ,LTD2023-05-30
08800053043106s-Clean Link Abutment NarrowDENTIS CO. ,LTD2023-05-30
08800053043113s-Clean Link Abutment NarrowDENTIS CO. ,LTD2023-05-30
08800053043120s-Clean Link Abutment NarrowDENTIS CO. ,LTD2023-05-30
08800053043137s-Clean Link Abutment NarrowDENTIS CO. ,LTD2023-05-30
08800053043144s-Clean Link Abutment NarrowDENTIS CO. ,LTD2023-05-30
08800053043151s-Clean Link Abutment NarrowDENTIS CO. ,LTD2023-05-30
08800053043168s-Clean Link Abutment NarrowDENTIS CO. ,LTD2023-05-30
08800053043175s-Clean Link Abutment NarrowDENTIS CO. ,LTD2023-05-30
08800053043182s-Clean Link Abutment NarrowDENTIS CO. ,LTD2023-05-30
08800053043199s-Clean Link Abutment NarrowDENTIS CO. ,LTD2023-05-30
08800053043205s-Clean Link Abutment NarrowDENTIS CO. ,LTD2023-05-30
08800053043212s-Clean Link Abutment NarrowDENTIS CO. ,LTD2023-05-30
08800053043229s-Clean Link Abutment NarrowDENTIS CO. ,LTD2023-05-30

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