FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Vericore Zirconia Blanks
DI: D040743541
·
Model: ZR PRO shaded B1
·
WHIP-MIX CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Vericore Zirconia Blanks
- Primary DI
- D040743541
- Version / Model
- ZR PRO shaded B1
- Catalog Number
- 74354
- Company Name
- WHIP-MIX CORPORATION
- Labeler DUNS
- 006385173
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-03-06
- Public Version
- 3
- Public Version Date
- 2021-08-25
- Public Version Status
- Update
- Public Device Record Key
- ebda35f9-7f09-48ff-ac68-b58de95dd4a6
- Distribution End Date
- 2021-02-25
Device Description
Vericore Zirconia blanks are made from pre-sintered zirconium dioxide intended to be used with CAD/CAM or manual milling machines. Vericore zirconia blanks are biocompatible and designed to fabricate zirconia structures.
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
- No
- 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 |
|---|---|---|---|---|
| 44727 | Dental porcelain/ceramic restoration kit | A collection of containers with different shades of porcelain (ceramic based material in powder form) intended to be used in prefabricated and custom-made dental restorations, e.g., artificial teeth on copings, crowns, or bridges. This kit is typically used in the dental laboratory. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | D040743541 | HIBCC |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 98mm X 20mm |