Cleared Traditional

Bone Screw

K251569 · Osstem Implant Co., Ltd. · Dental
Aug 2025
Decision
83d
Days
Class 2
Risk

About This 510(k) Submission

K251569 is an FDA 510(k) clearance for the Bone Screw, a Screw, Fixation, Intraosseous (Class II — Special Controls, product code DZL), submitted by Osstem Implant Co., Ltd. (Busan, KR). The FDA issued a Cleared decision on August 13, 2025, 83 days after receiving the submission on May 22, 2025. This device falls under the Dental review panel. Regulated under 21 CFR 872.4880.

Submission Details

510(k) Number K251569 FDA.gov
FDA Decision Cleared SESE
Date Received May 22, 2025
Decision Date August 13, 2025
Days to Decision 83 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code DZL — Screw, Fixation, Intraosseous
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.4880

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