FDA UDI
In Commercial Distribution
🇺🇸 United States
Zirdent Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank
DI: 06975018580025
·
Model: ST-C
·
Zirdent New Material Co.,Ltd
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Zirdent Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank
- Primary DI
- 06975018580025
- Version / Model
- ST-C
- Company Name
- Zirdent New Material Co.,Ltd
- Labeler DUNS
- 699451090
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-01-07
- Public Version
- 1
- Public Version Date
- 2022-01-17
- Public Version Status
- New
- Public Device Record Key
- fcd1f8ac-cdce-43a5-ab85-9f3d2598407d
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
- 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 |
|---|---|---|---|---|
| 62817 | Dental appliance fabrication material, combination-material | A dental material made of a combination of metal, ceramic, and/or synthetic polymer [e.g., polyethylene (PE)] 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 | 06975018580025 | GS1 | ||||
| Package | 16975018580022 | GS1 | 40 | In Commercial Distribution |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K212259 | 000 |