Identity
- Trade Name
- Iluzion FDA UDI
- Generic Name
- Dental appliance fabrication material, ceramic FDA UDI
- Device Name
- Iluzion dental zirconia FDA UDI
- Model / Reference
- LZN9816RB3 FDA UDI
- Description
- Iluzion dental zirconia FDA UDI
Identifiers
- Catalog Number
- LZN9816RB3 FDA UDI
- Primary DI / UDI-DI
- D815LZN9816RB30 FDA UDI
- FDA Product Code
- EIH FDA UDI
- GMDN Term
- Dental appliance fabrication material, ceramic FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.6660 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
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: Dental appliance fabrication material, ceramic
Iluzion is a high-performance, lab-developed zirconia dental material designed for single-use implantable and removable restorations. As an OPA Dental LLC product, Iluzion ensures the highest level of quality and safety for patients.
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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
- Opa Dental, Llc
Sources (1)
- FDA UDI 279f058e-0982-4824-aeab-34cab58091d6 34 fields · synced Jul 26, 2026