FDA UDI
In Commercial Distribution
🇺🇸 United States
Nacera® Pearl Natural
DI: EDDI35613039111
·
Model: 98H12 0M3
·
Dental Direkt GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Nacera® Pearl Natural
- Primary DI
- EDDI35613039111
- Version / Model
- 98H12 0M3
- Catalog Number
- 3561303911
- Company Name
- Dental Direkt GmbH
- Labeler DUNS
- 313214171
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-10-01
- Public Version
- 2
- Public Version Date
- 2025-12-08
- Public Version Status
- Update
- Public Device Record Key
- 6e5a0ccc-dc1a-42f5-8acb-69a740145a6b
Device Description
The Nacera® Pearl Natural zirconium dioxide milling blank made of yttrium-stabilized zirconium dioxide (5Y-TZP + 3Y-TZP) is a hybridlayer and is suitable for dental application of type II, class 5 in accordance with DIN EN ISO 6872 and they fulfill their material-specific requirements after specified final sintering.
Device Characteristics
- Single Use
- Yes
- 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 | EDDI35613039111 | HIBCC |
Customer Contacts
- Phone
- +495225863190
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K241579 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Outer Diameter | 98.3 | Millimeter | |
| Height | 12 | Millimeter |