Materialise Personalized Guides and Models for Craniomaxillofacial Surgery— 510(k) K243637

Substantially Equivalent

Materialise NV

FDA 510(k) clearance K243637 for Materialise Personalized Guides and Models for Craniomaxillofacial Surgery, Substantially Equivalent on 2025-02-21. Applicant: Materialise NV.

Clearance details

Applicant: Materialise NV
Product code: Code DZJ
Advisory panel: Dental
Date received: 2024-11-25
Decision date: 2025-02-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Leuven, BE

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