Cleared Traditional

Master-Pin X (MP Pin with thread) (36BMP000030 / MP30)

K250123 · Hager& Meisinger GmbH · Dental
Sep 2025
Decision
255d
Days
Class 2
Risk

About This 510(k) Submission

K250123 is an FDA 510(k) clearance for the Master-Pin X (MP Pin with thread) (36BMP000030 / MP30), a Screw, Fixation, Intraosseous (Class II — Special Controls, product code DZL), submitted by Hager& Meisinger GmbH (Neuss, DE). The FDA issued a Cleared decision on September 29, 2025, 255 days after receiving the submission on January 17, 2025. This device falls under the Dental review panel. Regulated under 21 CFR 872.4880.

Submission Details

510(k) Number K250123 FDA.gov
FDA Decision Cleared SESE
Date Received January 17, 2025
Decision Date September 29, 2025
Days to Decision 255 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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