FDA UDI
In Commercial Distribution
🇺🇸 United States
Materialise Mimics Enlight CMF
DI: 05404028001080
·
Model: Orthognathic and Trauma Planner
·
Materialise NV
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Materialise Mimics Enlight CMF
- Primary DI
- 05404028001080
- Version / Model
- Orthognathic and Trauma Planner
- Catalog Number
- Orthognathic and Trauma Planner
- Company Name
- Materialise NV
- Labeler DUNS
- 373139427
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2026-04-10
- Public Version
- 1
- Public Version Date
- 2026-04-20
- Public Version Status
- New
- Public Device Record Key
- 1e5bc630-2d03-4a5c-9489-d9bd2fba89bc
Device Description
Materialise Mimics Enlight CMF Orthognathic and Trauma Planner
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| LLZ | System, Image Processing, Radiological | Radiology | 892.2050 | 2 |
| DZJ | Driver, Wire, And Bone Drill, Manual | Dental | 872.4120 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 50484 | CAD/CAM software | A software program intended to provide computer-aided design (CAD) or computer-aided manufacturing (CAM) functionality for the production of patient-specific custom-made devices (e.g., orthopaedic implants, dental devices, anatomical models), treatment planning, simulation, and/or robotic capabilities for device production (e.g., 3-D printing). It may include functionality to upload patient-specific images and to facilitate communication between healthcare professionals. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05404028001080 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K223427 | 000 |