Identity
- Trade Name
- Nacera FDA UDI
- Generic Name
- Dental appliance fabrication material, ceramic FDA UDI
- Device Name
- With Nacera® Pearl you receive a German premium material of highly translucent zirconium oxide for natural-looking restorations. Available in white and in several colored shades, it provides the ideal basis for dental aesthetics. The blanks, each industrially manufactured in Germany using modern equipment, can be processed in most available milling machines and are characterized by their consistent color results and excellent machinability. Finished with a stain-and-glazing technique or using minimal stratification by Cut-Back, Nacera® Pearl is always a reliable quality foundation for monolithic crowns and bridges, as well as abutments and screw retained restorations. Material properties: • Multiple indication: suitable for everything from veneers to wide-span implant-supported bridges (up to 14 units) • Homogeneously shaded blanks ensure high reliability of colors and processes • superior stability: 4 Point Bending Strength 1200 MPa • Natural translucency increases the aesthetics of monolithic restorations • sintering temperature: 1500 °C • Perfect Fit thanks I.F.P. - Instant Fit Process • 3Y-TZP Zirconia, Pure Japanese Quality FDA UDI
- Model / Reference
- Pearl 2 FDA UDI
- Description
- With Nacera® Pearl you receive a German premium material of highly translucent zirconium oxide for natural-looking restorations. Available in white and in several colored shades, it provides the ideal basis for dental aesthetics. The blanks, each industrially manufactured in Germany using modern equipment, can be processed in most available milling machines and are characterized by their consistent color results and excellent machinability. Finished with a stain-and-glazing technique or using minimal stratification by Cut-Back, Nacera® Pearl is always a reliable quality foundation for monolithic crowns and bridges, as well as abutments and screw retained restorations. Material properties: • Multiple indication: suitable for everything from veneers to wide-span implant-supported bridges (up to 14 units) • Homogeneously shaded blanks ensure high reliability of colors and processes • superior stability: 4 Point Bending Strength 1200 MPa • Natural translucency increases the aesthetics of monolithic restorations • sintering temperature: 1500 °C • Perfect Fit thanks I.F.P. - Instant Fit Process • 3Y-TZP Zirconia, Pure Japanese Quality FDA UDI
Identifiers
- Catalog Number
- 3220WN3093 FDA UDI
- Primary DI / UDI-DI
- EDMC3220WN30930 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
- 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
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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Nacera by Doceram Medical Ceramics GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Doceram Medical Ceramics GmbH
Sources (1)
- FDA UDI d79b10a9-0d2c-4715-977b-17a382fd9194 37 fields · synced May 30, 2026