Identity
- Trade Name
- Materialise Mimics Enlight FDA UDI
- Generic Name
- CAD/CAM software FDA UDI
- Device Name
- Materialise Mimics Enlight FDA UDI
- Model / Reference
- Materialise Mimics Enlight FDA UDI
- Description
- Materialise Mimics Enlight FDA UDI
Identifiers
- Catalog Number
- Materialise Mimics Enlight FDA UDI
- Primary DI / UDI-DI
- 05404028000199 FDA UDI
- 510(k) Number
- K190874 FDA UDI
- FDA Product Code
- LLZ FDA UDI
- GMDN Term
- CAD/CAM software FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.2050 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: CAD/CAM software
Materialise Mimics Enlight by Materialise NV — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as CAD/CAM software.
- CEREC — Sirona Dental Systems GmbH · Class II
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- CAD/CAM Software — Sirona Dental Systems GmbH · Class II
- CEREC Guide — Sirona Dental Systems GmbH · Class I
- CEREC Guide — Sirona Dental Systems GmbH · Class I
- CEREC Guide — Sirona Dental Systems GmbH · Class I
- CAD/CAM Software — Sirona Dental Systems GmbH · Class II
- CEREC Guide — Sirona Dental Systems GmbH · Class I
Cleared under the same submission
K190874 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Materialise NV
Sources (1)
- FDA UDI 0d175656-312f-4b1d-8de0-d45215af06cc 35 fields · synced May 31, 2026