Identity
- Trade Name
- Signature FDA UDI
- Generic Name
- CAD/CAM software FDA UDI
- Device Name
- Signature Planner FDA UDI
- Model / Reference
- Signature Planner FDA UDI
- Description
- Signature Planner FDA UDI
Identifiers
- Catalog Number
- Signature Planner FDA UDI
- Primary DI / UDI-DI
- E314SIGNATURE0 FDA UDI
- 510(k) Number
- K140257 FDA UDI
- FDA Product Code
- JWH FDA UDIMBH FDA UDIOOG FDA UDIOIY FDA UDIMBV FDA UDI
- GMDN Term
- CAD/CAM software FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3560 FDA UDI888.3565 FDA UDI
- Commercial Distribution
- Not 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
No
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
No
FDA UDI
Signature by Materialise NV — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Materialise NV
Sources (1)
- FDA UDI e3bf5d63-078e-4647-a69d-24ac4b509aa2 36 fields · synced May 31, 2026