FDA 510(k)
FDA class 2
Substantially Equivalent
🇧🇪 Belgium
Materialise Personalized Guides and Models for Craniomaxillofacial Surgery
K Number: K243637
·
Decision Feb 21, 2025
Classifications
1
FEI Numbers
47
Registration Numbers
47
Same Product Code
31
Applicant Total
61
Review Days
88
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Basic Information
- Device Name
- Materialise Personalized Guides and Models for Craniomaxillofacial Surgery
- K Number
- K243637
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.4120
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Materialise NV
- Date Received
- November 25, 2024
- Decision Date
- February 21, 2025
- Product Code
- DZJ
- Advisory Committee
- Dental
- Review Advisory Committee
- DE
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| DZJ | Driver, Wire, And Bone Drill, Manual | FDA class 2 | Dental |
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