Cleared Traditional

Materialise Personalized Guides and Models for Craniomaxillofacial Surgery

K243637 · Materialise NV · Dental
Feb 2025
Decision
88d
Days
Class 2
Risk

About This 510(k) Submission

K243637 is an FDA 510(k) clearance for the Materialise Personalized Guides and Models for Craniomaxillofacial Surgery, a Driver, Wire, And Bone Drill, Manual (Class II — Special Controls, product code DZJ), submitted by Materialise NV (Leuven, BE). The FDA issued a Cleared decision on February 21, 2025, 88 days after receiving the submission on November 25, 2024. This device falls under the Dental review panel. Regulated under 21 CFR 872.4120.

Submission Details

510(k) Number K243637 FDA.gov
FDA Decision Cleared SESE
Date Received November 25, 2024
Decision Date February 21, 2025
Days to Decision 88 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code DZJ — Driver, Wire, And Bone Drill, Manual
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.4120