Identity
- Trade Name
- Trusana EUDAMEDFDA UDI
- Generic Name
- Resin artificial teeth FDA UDI
- Device Name
- 3D resin EUDAMED500ml 3D Printing Resin 405nm Shade 51 for teeth FDA UDI
- Model / Reference
- TRU405-51-N-TRI EUDAMEDFDA UDI
- Description
- 500ml 3D Printing Resin 405nm Shade 51 for teeth FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00842326199538 EUDAMEDFDA UDI
- Basic UDI-DI
- 084232613DteethUU EUDAMED
- FDA Product Code
- PZY FDA UDI
- EMDN Code
- Q0102050101 TEMPORARY TEETH RESINS EUDAMED
- GMDN Term
- Resin artificial teeth FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 872.3590 FDA UDI
- Market of Registration
- France EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Dental appliance fabrication material, resin
Trusana by The Myerson Company Limited — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 084232613DteethUU | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- The Myerson Company Limited
- EUDAMED SRN
- TT-MF-000045141
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (2)
- EUDAMED 7d31e085-4670-454e-81ec-49acfbd7ebe2 61 fields · synced May 30, 2026
- FDA UDI af41f09e-e700-40bf-a85d-5552e577ffe7 35 fields · synced May 29, 2026