Cleared Traditional

SD Implant System

K241703 · Arum Dentistry Co., Ltd. · Dental
Feb 2025
Decision
256d
Days
Class 2
Risk

About This 510(k) Submission

K241703 is an FDA 510(k) clearance for the SD 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 February 24, 2025, 256 days after receiving the submission on June 13, 2024. This device falls under the Dental review panel. Regulated under 21 CFR 872.3640.

Submission Details

510(k) Number K241703 FDA.gov
FDA Decision Cleared SESE
Date Received June 13, 2024
Decision Date February 24, 2025
Days to Decision 256 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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