FDA Registration
Active
🇺🇸 United States
BruxZir® Esthetic Milling Blank C1 GD 20mm Z
Reg #: 3011649314
·
FEI: 3011649314
·
Expires 2025
Products
1
Proprietary Names
93
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- PRISMATIK DENTALCRAFT, INC.
- Registration Number
- 3011649314
- FEI Number
- 3011649314
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 2144 Michelson Drive
- City
- Irvine
- State
- CA
- ZIP
- 92612
- Country
- US
Regulatory Submissions
- 510(k) Number
- K213425
Owner / Operator
- Firm Name
- PRISMATIK DENTALCRAFT, INC.
- Operator Number
- 10043585
- Address
- 2144 Michelson Drive
- City
- Irvine
- State
- CA
- Postal Code
- 92612
- Country
- US
- Correspondent
- Michelle Gallup
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Powder, Porcelain | EIH | Class 2 | Dental | No | 2021-11-17 |
Proprietary Names
BruxZir® Esthetic Milling Blank C1 GD 20mm Z
BruxZir® Esthetic Milling Blank BL1 GD 16mm Z
BruxZir® Esthetic Milling Blank White 16mm Z
BruxZir® Esthetic Milling Blank A3 GD 20mm Z
BruxZir® Esthetic Milling Blank BL3 GD 20mm Z
BruxZir® Esthetic Milling Blank A1 14mm Z
BruxZir® Esthetic Milling Blank A3.5 20mm Z
BruxZir® Esthetic Milling Blank D3 GD 20mm Z
BruxZir® Esthetic Milling Blank D3 GD 16mm Z
BruxZir® Esthetic Milling Blank BL1 25mm Z
BruxZir® Esthetic Milling Blank C3 GD 20mm Z
BruxZir® Esthetic Milling Blank A4 GD 14mm Z
BruxZir® Esthetic Milling Blank A2 GD 16mm Z
BruxZir® Esthetic Milling Blank A2 GD 20mm Z
BruxZir® Esthetic Milling Blank A2 GD 14mm Z
BruxZir® Esthetic Milling Blank A1 GD 20mm Z
BruxZir® Esthetic Milling Blank BL3 GD 25mm Z
BruxZir® Esthetic Milling Blank A3 14mm Z
BruxZir® Esthetic Milling Blank A3 GD 25mm Z
BruxZir® Esthetic Milling Blank C1 GD 14mm Z
BruxZir® Esthetic Milling Blank White GD 14mm Z
BruxZir® Esthetic Milling Blank A1 GD 14mm Z
BruxZir® Esthetic Milling Blank A3.5 GD 25mm Z
BruxZir® Esthetic Milling Blank B2 20mm Z
BruxZir® Esthetic Milling Blank BL1 GD 25mm Z
BruxZir® Esthetic Milling Blank B2 GD 20mm Z
BruxZir® Esthetic Milling Blank D3 14mm Z
BruxZir® Esthetic Milling Blank A4 16mm Z
BruxZir® Esthetic Milling Blank D2 GD 20mm Z
BruxZir® Esthetic Milling Blank B4 GD 14mm Z
BruxZir® Esthetic Milling Blank A3.5 GD 16mm Z
BruxZir® Esthetic Milling Blank B2 GD 16mm Z
BruxZir® Esthetic Milling Blank D4 GD 14mm Z
BruxZir® Esthetic Milling Blank A2 14mm Z
BruxZir® Esthetic Milling Blank B1 16mm Z
BruxZir® Esthetic Milling Blank B1 GD 20mm Z
BruxZir® Esthetic Milling Blank C4 GD 25mm Z
BruxZir® Esthetic Milling Blank C2 GD 25mm Z
BruxZir® Esthetic Milling Blank A1 GD 25mm Z
BruxZir® Esthetic Milling Blank BL1 GD 20mm Z
BruxZir® Esthetic Milling Blank B1 GD 25mm Z
BruxZir® Esthetic Milling Blank C3 GD 25mm Z
BruxZir® Esthetic Milling Blank A4 GD 20mm Z
BruxZir® Esthetic Milling Blank C1 25mm Z
BruxZir® Esthetic Milling Blank White GD 16mm Z
BruxZir® Esthetic Milling Blank B4 GD 25mm Z
BruxZir® Esthetic Milling Blank BL1 16mm Z
BruxZir® Esthetic Milling Blank D3 GD 25mm Z
BruxZir® Esthetic Milling Blank B3 GD 20mm Z
BruxZir® Esthetic Milling Blank C3 GD 16mm Z
BruxZir® Esthetic Milling Blank D2 GD 16mm Z
BruxZir® Esthetic Milling Blank BL1 GD 14mm Z
BruxZir® Esthetic Milling Blank D4 GD 25mm Z
BruxZir® Esthetic Milling Blank A2 GD 25mm Z
BruxZir® Esthetic Milling Blank A3 GD 16mm Z
BruxZir® Esthetic Milling Blank BL3 GD 16mm Z
BruxZir® Esthetic Milling Blank A1 GD 16mm Z
BruxZir® Esthetic Milling Blank B3 GD 16mm Z
BruxZir® Esthetic Milling Blank BL1 20mm Z
BruxZir® Esthetic Milling Blank D2 GD 14mm Z
BruxZir® Esthetic Milling Blank A3.5 GD 14mm Z
BruxZir® Esthetic Milling Blank C4 GD 14mm Z
BruxZir® Esthetic Milling Blank B3 14mm Z
BruxZir® Esthetic Milling Blank White GD 25mm Z
BruxZir® Esthetic Milling Blank C4 GD 16mm Z
BruxZir® Esthetic Milling Blank B3 GD 25mm Z
BruxZir® Esthetic Milling Blank D4 GD 20mm Z
BruxZir® Esthetic Milling Blank B1 GD 14mm Z
BruxZir® Esthetic Milling Blank C1 GD 16mm Z
BruxZir® Esthetic Milling Blank C2 GD 14mm Z
BruxZir® Esthetic Milling Blank D4 GD 16mm Z
BruxZir® Esthetic Milling Blank C2 GD 16mm Z
BruxZir® Esthetic Milling Blank BL3 GD 14mm Z
BruxZir® Esthetic Milling Blank A2 16mm Z
BruxZir® Esthetic Milling Blank C1 GD 25mm Z
BruxZir® Esthetic Milling Blank BL3 20mm Z
BruxZir® Esthetic Milling Blank D3 GD 14mm Z
BruxZir® Esthetic Milling Blank A4 GD 25mm Z
BruxZir® Esthetic Milling Blank D2 GD 25mm Z
BruxZir® Esthetic Milling Blank B2 GD 25mm Z
BruxZir® Esthetic Milling Blank White GD 20mm Z
BruxZir® Esthetic Milling Blank B1 GD 16mm Z
BruxZir® Esthetic Milling Blank C2 GD 20mm Z
BruxZir® Esthetic Milling Blank C4 GD 20mm Z
BruxZir® Esthetic Milling Blank B2 GD 14mm Z
BruxZir® Esthetic Milling Blank C3 GD 14mm Z
BruxZir® Esthetic Milling Blank A3 GD 14mm Z
BruxZir® Esthetic Milling Blank A4 GD 16mm Z
BruxZir® Esthetic Milling Blank B4 GD 20mm Z
BruxZir® Esthetic Milling Blank A3.5 GD 20mm Z
BruxZir® Esthetic Milling Blank B3 GD 14mm Z
BruxZir® Esthetic Milling Blank C4 25mm Z
BruxZir® Esthetic Milling Blank B4 GD 16mm Z
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device