FDA.report

510(k) K242978

Device
Geo Abutment
Applicant
Geomedi Co,., Ltd.
510(k) number
K242978
Product code
NHA
Decision
Substantially Equivalent (SESE)
Decision date
2025-06-16
Date received
2024-09-26
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
Jihyo Lee
Address
Unit D, #B112, 702, 703, 704, 705, 709-1, 810-1, 811 Indeokwon It Valley Uiwang-Si KR 16006 16006

FDA Registration Numbers

Source Documents

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

Related GUDID Devices

Primary DIBrandCompanyPublished
08800028733018Geo ScrewGEOMEDI INC.2025-06-30
08800028733629Geo ScrewGEOMEDI INC.2025-06-30
08800028733612Geo ScrewGEOMEDI INC.2025-06-30
08800028733605Geo ScrewGEOMEDI INC.2025-06-30
08800028733599Geo ScrewGEOMEDI INC.2025-06-30
08800028733582Geo ScrewGEOMEDI INC.2025-06-30
08800028733575Geo ScrewGEOMEDI INC.2025-06-30
08800028733094Geo ScrewGEOMEDI INC.2025-06-30
08800028733087Geo ScrewGEOMEDI INC.2025-06-30
08800028733025Geo ScrewGEOMEDI INC.2025-06-30
08800028712884Geo CMFit AbutmentGEOMEDI INC.2025-06-27
08800028715113Geo Multibase AbutmentGEOMEDI INC.2025-06-27
08800028712853Geo CMFit AbutmentGEOMEDI INC.2025-06-27
08800028712860Geo CMFit AbutmentGEOMEDI INC.2025-06-27
08800028712877Geo CMFit AbutmentGEOMEDI INC.2025-06-27
08800028712976Geo CMFit AbutmentGEOMEDI INC.2025-06-27
08800028713089Geo CMFit AbutmentGEOMEDI INC.2025-06-27
08800028713096Geo CMFit AbutmentGEOMEDI INC.2025-06-27
08800028713249Geo CMFit AbutmentGEOMEDI INC.2025-06-27
08800028713256Geo CMFit AbutmentGEOMEDI INC.2025-06-27
08800028713263Geo CMFit AbutmentGEOMEDI INC.2025-06-27
08800028713270Geo CMFit AbutmentGEOMEDI INC.2025-06-27
08800028714321Geo CMFit AbutmentGEOMEDI INC.2025-06-27
08800028715038Geo Multibase AbutmentGEOMEDI INC.2025-06-27
08800028715045Geo Multibase AbutmentGEOMEDI INC.2025-06-27
08800028715052Geo Multibase AbutmentGEOMEDI INC.2025-06-27
08800028715069Geo Multibase AbutmentGEOMEDI INC.2025-06-27
08800028715090Geo Multibase AbutmentGEOMEDI INC.2025-06-27
08800028715106Geo Multibase AbutmentGEOMEDI INC.2025-06-27
08800028715120Geo Multibase AbutmentGEOMEDI INC.2025-06-27

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