FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Vericore Zirconia Blanks
DI: D040728421
·
Model: HT Shaded BL
·
WHIP-MIX CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Vericore Zirconia Blanks
- Primary DI
- D040728421
- Version / Model
- HT Shaded BL
- Catalog Number
- 72842
- Company Name
- WHIP-MIX CORPORATION
- Labeler DUNS
- 006385173
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-08-22
- Public Version
- 5
- Public Version Date
- 2021-08-25
- Public Version Status
- Update
- Public Device Record Key
- bf6176f3-0528-49e2-9a98-7602e3f9140b
- Distribution End Date
- 2021-02-25
Device Description
Whip Mix Vericore® Zirconia Blanks are made from Yttria stabilized zirconium powder. The powder is pressed into either a circular disc or rectangular block. The product is then sintered after pressing and this process is called pre-sintering. The customer then mills the doctor prescribed restoration/framework from the blank and then performs the final sintering. This may include available staining and glazing, but the stain and glaze products are not supplied by Whip Mix. They are available in a variety of sizes and shades.
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 |
|---|---|---|---|---|
| 38594 | Custom-made dental crown, ceramic | A device made totally of ceramic material, and created for a specific post-pubescent/adult patient (custom-made), that functions as an artificial covering to replace the major part, or the whole part, of the clinical crown of a tooth. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | D040728421 | HIBCC |
Customer Contacts
- Phone
- 5026345357
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 10mm X 98mm |