FDA UDI
In Commercial Distribution
🇺🇸 United States
Nacera
DI: EDMC35683030960
·
Model: Pearl Natural B2
·
DOCERAM medical ceramics GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Nacera
- Primary DI
- EDMC35683030960
- Version / Model
- Pearl Natural B2
- Catalog Number
- 3568303096
- Company Name
- DOCERAM medical ceramics GmbH
- Labeler DUNS
- 537713567
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-04-14
- Public Version
- 2
- Public Version Date
- 2024-05-27
- Public Version Status
- Update
- Public Device Record Key
- a8889cff-57cc-49d2-a025-3d21c904973c
Device Description
3Y/5Y-TZP zirconium oxide, pre-sintered white fired condition, high translucent, translucency gradient, multi-shade. Suitable for single crowns, inlays, onlays, veneers and bridges up to 16 units. Bi-axial bending strength from 1,100 – 1,350 MPa.
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
- No
- 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 | EDMC35683030960 | HIBCC |
Customer Contacts
- Phone
- +495225863190
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Height | 20 | Millimeter |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 10 – 50 Degrees Celsius