Bone Screw— 510(k) K251569

Name: FDA 510(k) clearance K251569
Creator: U.S. Food and Drug Administration
Published: 2025-08-13

Substantially Equivalent

Osstem Implant Co., Ltd.

FDA 510(k) clearance K251569 for Bone Screw, Substantially Equivalent on 2025-08-13. Applicant: Osstem Implant Co., Ltd.. Device class: 2.

Clearance details

Applicant: Osstem Implant Co., Ltd.
Product code: Code DZL
Device class: Class 2
Regulation: 21 CFR 872.4880
Advisory panel: Dental
Date received: 2025-05-22
Decision date: 2025-08-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Busan, KR

Download summary PDF View on FDA.gov ↗

Recent devices under product code DZL

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K254286 — Guided Bone Regeneration System2026-08-24
K250123 — Master-Pin X (MP Pin with thread) (36BMP000030 / MP30)2025-09-29
K243190 — USTOMED Bone Fixation/Bone Augmentation Systems - PIN2025-06-27
K233419 — GBR System2025-01-03
K240321 — MP Pin flat without thread (36BMP000020/MP20)2024-10-17

More clearances from Osstem Implant Co., Ltd.

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K251434 — Healing Abutment System2026-03-04
K242521 — Estar-ZE2024-11-20
K233806 — T2 Plus2024-09-06
K233194 — TS Abutment System2024-02-20
K232220 — SS Abutment System2023-12-05

Adverse events under product code DZL

product code DZL

Injury: 168
Total: 168

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.