Identity
- Trade Name
- Individo Lux FDA UDI
- Generic Name
- Dental base plate FDA UDI
- Device Name
- lndivido Lux blue opaque and lndivido Lux transparent blue are opaque respectively transparent light-curing resins in form of contoured plates for maxillae and mandibles for the fabrication of individual trays for use in crown, bridge and total prosthetic technique as well as for the fabrication of bases for bite patterns and odontograms. They are ready for use and easy to handle without any odor nuisance. FDA UDI
- Model / Reference
- 2403 FDA UDI
- Description
- lndivido Lux blue opaque and lndivido Lux transparent blue are opaque respectively transparent light-curing resins in form of contoured plates for maxillae and mandibles for the fabrication of individual trays for use in crown, bridge and total prosthetic technique as well as for the fabrication of bases for bite patterns and odontograms. They are ready for use and easy to handle without any odor nuisance. FDA UDI
Identifiers
- Catalog Number
- 2403 FDA UDI
- Primary DI / UDI-DI
- E22124031 FDA UDI
- FDA Product Code
- EBH FDA UDI
- GMDN Term
- Dental base plate FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.3670 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
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 base plate
Individo Lux by VOCO GmbH — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- VOCO GmbH
Sources (2)
- FDA UDI a6ad9577-77c5-433b-9628-399f29c59477 35 fields · synced Jun 19, 2026
- EUDAMED 1 fields · synced Jun 4, 2026