FDA.report

510(k) K230203

Device
Dentis I-FIX Abutment
Applicant
Dentis Co., Ltd.
510(k) number
K230203
Product code
NHA
Decision
Substantially Equivalent (SESE)
Decision date
2023-05-03
Date received
2023-01-25
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
N
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
EunJin Shin
Address
99, Seongseoseo-Ro Dalseo-Gu Daegu KR 42718 42718

FDA Registration Numbers

Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON

Related GUDID Devices

Primary DIBrandCompanyPublished
08806169132048I-FIX Abutment ScrewDENTIS CO. ,LTD2023-05-08
08800053040587I-FIX Angled Type Fixture Healing AbutmentDENTIS CO. ,LTD2023-05-08
08800053040594I-FIX Angled Type Fixture Healing AbutmentDENTIS CO. ,LTD2023-05-08
08800053072298I-FIX Angled Type Fixture Healing Abutment ScrewDENTIS CO. ,LTD2023-05-08
08800053072304I-FIX Angled Type Fixture Healing Abutment ScrewDENTIS CO. ,LTD2023-05-08
08800053083010I-FIX Angled Type Fixture Healing AbutmentDENTIS CO. ,LTD2023-05-08
08800053083027I-FIX Angled Type Fixture Healing AbutmentDENTIS CO. ,LTD2023-05-08
08806169128393I-FIX Angled Type Fixture Healing AbutmentDENTIS CO. ,LTD2023-05-08
08806169128409I-FIX Angled Type Fixture Healing AbutmentDENTIS CO. ,LTD2023-05-08
08806169189356I-FIX Angled Type Fixture Healing AbutmentDENTIS CO. ,LTD2023-05-08
08806169134011I-FIX Angled Type Fixture Healing Abutment ScrewDENTIS CO. ,LTD2023-05-08
08806169134028I-FIX Angled Type Fixture Healing Abutment ScrewDENTIS CO. ,LTD2023-05-08
08806169186072I-FIX Cemented AbutmentDENTIS CO. ,LTD2023-05-08
08806169186089I-FIX Cemented AbutmentDENTIS CO. ,LTD2023-05-08
08806169186096I-FIX Free AbutmentDENTIS CO. ,LTD2023-05-08
08806169186102I-FIX Free AbutmentDENTIS CO. ,LTD2023-05-08
08806169189349I-FIX Angled Type Fixture Healing AbutmentDENTIS CO. ,LTD2023-05-08

Other 510(k) Records For Product Code NHA

510(k)DeviceApplicantDecision date
K253372ET Healing Abutments; ET Scan Healing Abutments; EK Scan Healing AbutmentsHiossen, Inc.2026-05-14
K260460Neodent Gold Hue Custom Abutments, Medentika Custom Abutments Gold HueInstitut Straumann AG2026-05-07
K253804DESS Dental Smart SolutionsTerrats Medical SL2026-04-16
K260555LOCATOR® Angled AbutmentZest Anchors, LLC2026-04-09
K251434Healing Abutment SystemOsstem Implant Co., Ltd.2026-03-04
K251515Solidex® Ti-Links and ScrewsCreoDent Hudson Valley2026-02-10
K251427EK MULTI ANGLED 30 ABUTMENTHiossen, Inc.2026-01-29
K243732Multi-Unit DAS SystemTalladium España, SL2026-01-29
K253315Straumann Variobase Abutments XC for Bridge/BarInstitut Straumann AG2026-01-22
K253253IPDmilled BlanksImplant Protesis Dental 2004, S.L.2026-01-22
K252727Neodent InLab Validated WorkflowJJGC Indústria e Comércio de Materiais Dentários S.A.2026-01-07
K253341Custom Abutments ASMedentika GmbH2025-12-23
K253312OrangeCAD Med AbutmentsOrangecad Med GmbH2025-12-23
K252320SIMDA AbutmentsSimda Co., Ltd.2025-12-18
K252343Atlantis® Abutments in TitaniumDentsply Sirona2025-12-09