Master-Pin X (MP Pin with thread) (36BMP000030 / MP30)— 510(k) K250123

Name: FDA 510(k) clearance K250123
Creator: U.S. Food and Drug Administration
Published: 2025-09-29

Substantially Equivalent

Hager& Meisinger GmbH

FDA 510(k) clearance K250123 for Master-Pin X (MP Pin with thread) (36BMP000030 / MP30), Substantially Equivalent on 2025-09-29. Applicant: Hager& Meisinger GmbH. Device class: 2.

Clearance details

Applicant: Hager& Meisinger GmbH
Product code: Code DZL
Device class: Class 2
Regulation: 21 CFR 872.4880
Advisory panel: Dental
Date received: 2025-01-17
Decision date: 2025-09-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Neuss, DE

Download summary PDF View on FDA.gov ↗

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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

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K201210 — The Micro Screw System, Micro Screw System Basic2021-10-08
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K170287 — Dental Implants OKTAGON Bone Level Tapered Design2017-05-24
K162073 — Dental Implants OKTAGON Tissue Level and Bone Level2017-02-24

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.