Nacera
Basic Information
- Brand Name
- Nacera
- Primary DI
- EDMC3240WN30920
- Version / Model
- Pearl 4
- Catalog Number
- 3240WN3092
- Company Name
- DOCERAM medical ceramics GmbH
- Labeler DUNS
- 537713567
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-12-21
- Public Version
- 4
- Public Version Date
- 2018-07-24
- Public Version Status
- Update
- Public Device Record Key
- cf2fa1d4-5ef4-426f-8890-47fe8b561f8d
- Distribution End Date
- 2017-10-31
Device 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
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| EIH | Powder, Porcelain | Dental | 872.6660 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 16187 | Dental appliance fabrication material, ceramic | A dental material made of ceramic materials (e.g., zirconium oxide) intended to be used to manufacture a final dental prosthesis (e.g., a dental implant, removable dentures, crown, bridge) for patient use. It is used to create implantable and removable restorations using manual or computer-aided design/computer-aided manufacturing (CAD/CAM) technology. After application, this material cannot be reused for fabrication. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | EDMC3240WN30920 | HIBCC |
Customer Contacts
- Phone
- +492319256680
- [email protected]
Storage Conditions
- Type
- Storage Environment Humidity
- Temperature Range
- 20 – 50 Percent (%) Relative Humidity
- Type
- Storage Environment Temperature
- Temperature Range
- 10 – 50 Degrees Celsius