FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Nacera
DI: EDMC48023000000
·
Model: Hybrid D2 Disc
·
DOCERAM medical ceramics GmbH
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Nacera
- Primary DI
- EDMC48023000000
- Version / Model
- Hybrid D2 Disc
- Catalog Number
- 4802300000
- 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
- 2017-11-17
- Public Version
- 8
- Public Version Date
- 2024-05-24
- Public Version Status
- Update
- Public Device Record Key
- a5b20e0b-02f0-4af2-8cf6-b9b581d588bf
- Distribution End Date
- 2024-05-23
Device Description
Fully polymerized composite with optimized, high-density filler technology. Radiopaque, 8 shades. Flexural strength: 175 MPa (typical value). Modulus of elasticity: 9900 MPa (typical value).
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 |
|---|---|---|---|---|
| EBF | Material, Tooth Shade, Resin | Dental | 872.3690 | 2 |
| 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 | EDMC48023000000 | HIBCC |
Customer Contacts
- Phone
- +49231925025952
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Height | 15 | Millimeter |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 5 – 50 Degrees Celsius