Cleared Traditional

SD TL Implant System

K250280 · Arum Dentistry Co., Ltd. · Dental
Jul 2025
Decision
173d
Days
Class 2
Risk

About This 510(k) Submission

K250280 is an FDA 510(k) clearance for the SD TL Implant System, a Implant, Endosseous, Root-form (Class II — Special Controls, product code DZE), submitted by Arum Dentistry Co., Ltd. (Daejeon, KR). The FDA issued a Cleared decision on July 23, 2025, 173 days after receiving the submission on January 31, 2025. This device falls under the Dental review panel. Regulated under 21 CFR 872.3640.

Submission Details

510(k) Number K250280 FDA.gov
FDA Decision Cleared SESE
Date Received January 31, 2025
Decision Date July 23, 2025
Days to Decision 173 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code DZE — Implant, Endosseous, Root-form
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.3640

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