FDA.report

510(k) K242753

Device
SD TL Implant System
Applicant
Arum Dentistry Co., Ltd.
510(k) number
K242753
Product code
DZE
Decision
Substantially Equivalent (SESE)
Decision date
2025-01-06
Date received
2024-09-12
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
Choi Won-Yi
Address
23 Gukjegwahak 11-Ro, Yuseong-Gu Daejeon KR 34002 34002

FDA Registration Numbers

Source Documents

510(k) summary PDF

Related GUDID Devices

Primary DIBrandCompanyPublished
08800265644245SD Tissue Level FixtureARUM DENTISTRY Co., Ltd.2026-03-12
08800265646348SD Tissue Level FixtureARUM DENTISTRY Co., Ltd.2026-03-12
08800265645990SD Tissue Level FixtureARUM DENTISTRY Co., Ltd.2026-03-12
08800265645976SD Tissue Level FixtureARUM DENTISTRY Co., Ltd.2026-03-12
08800265645891SD Tissue Level FixtureARUM DENTISTRY Co., Ltd.2026-03-12
08800265645471SD Tissue Level FixtureARUM DENTISTRY Co., Ltd.2026-03-12
08800265644313SD Tissue Level FixtureARUM DENTISTRY Co., Ltd.2026-03-12
08800265644306SD Tissue Level FixtureARUM DENTISTRY Co., Ltd.2026-03-12
08800265644290SD Tissue Level FixtureARUM DENTISTRY Co., Ltd.2026-03-12
08800265644283SD Tissue Level FixtureARUM DENTISTRY Co., Ltd.2026-03-12
08800265644276SD Tissue Level FixtureARUM DENTISTRY Co., Ltd.2026-03-12
08800265644269SD Tissue Level FixtureARUM DENTISTRY Co., Ltd.2026-03-12
08800265644252SD Tissue Level FixtureARUM DENTISTRY Co., Ltd.2026-03-12
08800265646355SD Tissue Level FixtureARUM DENTISTRY Co., Ltd.2026-03-12
08800265644238SD Tissue Level FixtureARUM DENTISTRY Co., Ltd.2026-03-12
08800265644221SD Tissue Level FixtureARUM DENTISTRY Co., Ltd.2026-03-12
08800265644214SD Tissue Level FixtureARUM DENTISTRY Co., Ltd.2026-03-12
08800265644207SD Tissue Level FixtureARUM DENTISTRY Co., Ltd.2026-03-12
08800265644191SD Tissue Level FixtureARUM DENTISTRY Co., Ltd.2026-03-12
08800265644184SD Tissue Level FixtureARUM DENTISTRY Co., Ltd.2026-03-12
08800265644177SD Tissue Level FixtureARUM DENTISTRY Co., Ltd.2026-03-12
08800265644160SD Tissue Level FixtureARUM DENTISTRY Co., Ltd.2026-03-12
08800265644153SD Tissue Level FixtureARUM DENTISTRY Co., Ltd.2026-03-12
08800265644146SD Tissue Level FixtureARUM DENTISTRY Co., Ltd.2026-03-12
08800265644139SD Tissue Level FixtureARUM DENTISTRY Co., Ltd.2026-03-12
08800265644122SD Tissue Level FixtureARUM DENTISTRY Co., Ltd.2026-03-12
08809982756682SD Tissue Level FixtureARUM DENTISTRY Co., Ltd.2026-03-12
08809982758839Multi Pre-Milled CylinderARUM DENTISTRY Co., Ltd.2026-03-12
08809982758822Multi Pre-Milled CylinderARUM DENTISTRY Co., Ltd.2026-03-12
08809982758815Multi Pre-Milled CylinderARUM DENTISTRY Co., Ltd.2026-03-12

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K251938GEN5 and GEN5+ Dental Implant SystemParagon Implant Mfg., LLC2025-10-30
K243078HexaPLUS S OneDrill Implant SystemOsseofuse International, Inc.2025-10-10