FDA Registration
Active
🇺🇸 United States
BruxZir® Esthetic A2 12mm Z
Reg #: 3011649314
·
FEI: 3011649314
·
Expires 2025
Products
1
Proprietary Names
148
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
- K240882
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 | 2024-05-02 |
Proprietary Names
BruxZir® Esthetic A2 12mm Z
BruxZir® Esthetic C2 GD 16mm Z
BruxZir® Esthetic A1 GD 25mm Z
BruxZir® Esthetic C1 GD 14mm Z
BruxZir® Esthetic White GD 25mm Z
BruxZir® Esthetic A3.5 16mm Z
BruxZir® Esthetic C1 GD 20mm Z
BruxZir® Esthetic Bleach GD 20mm Z
BruxZir® Esthetic B2 GD 25mm Z
BruxZir® Esthetic B2 16mm Z
BruxZir® Esthetic A2 GD 25mm Z
BruxZir® Esthetic C4 20mm Z
BruxZir® Esthetic B2 GD 16mm Z
BruxZir Esthetic GL Single Unit Block - A2
BruxZir® Esthetic B1 GD 20mm Z
BruxZir Esthetic GL Single Unit Block - B1
BruxZir Esthetic GL Single Unit Block - D4
BruxZir® Esthetic D3 GD 25mm Z
BruxZir® Esthetic White GD 20mm Z
BruxZir Esthetic GL Single Unit Block - Bleach
BruxZir® Esthetic White GD 16mm Z
BruxZir® Esthetic A2 GD 20mm Z
BruxZir® Esthetic A3.5 GD 20mm Z
BruxZir® Esthetic B1 GD 16mm Z
BruxZir® Esthetic A3 GD 25mm Z
BruxZir® Esthetic C2 GD 14mm Z
BruxZir® Esthetic B3 20mm Z
BruxZir® Esthetic A2 16mm Z
BruxZir® Esthetic C4 16mm Z
BruxZir® Esthetic A2 GD 14mm Z
BruxZir® Esthetic C3 GD 25mm Z
BruxZir® Esthetic Bleach GD 16mm Z
BruxZir® Esthetic Bleach 12mm Z
BruxZir® Esthetic C2 GD 20mm Z
BruxZir® Esthetic D4 GD 16mm Z
BruxZir® Esthetic Bleach 20mm Z
BruxZir® Esthetic B2 25mm Z
BruxZir® Esthetic C1 25mm Z
BruxZir® Esthetic B4 20mm Z
BruxZir® Esthetic A4 GD 25mm Z
BruxZir® Esthetic B1 16mm Z
BruxZir® Esthetic D3 16mm Z
BruxZir® Esthetic C3 GD 20mm Z
BruxZir® Esthetic A4 GD 14mm Z
BruxZir® Esthetic C3 GD 14mm Z
BruxZir Esthetic GL Single Unit Block - A3.5
BruxZir® Esthetic White 25mm Z
BruxZir® Esthetic C3 GD 16mm Z
BruxZir® Esthetic C1 20mm Z
BruxZir® Esthetic A2 GD 16mm Z
BruxZir® Esthetic A1 20mm Z
BruxZir® Esthetic B3 GD 25mm Z
BruxZir® Esthetic B3 GD 14mm Z
BruxZir® Esthetic A3 16mm Z
BruxZir® Esthetic A1 GD 16mm Z
BruxZir® Esthetic B3 16mm Z
BruxZir® Esthetic D4 GD 25mm Z
BruxZir® Esthetic B2 GD 20mm Z
BruxZir® Esthetic C1 GD 16mm Z
BruxZir® Esthetic D2 GD 20mm Z
BruxZir® Esthetic A3 GD 20mm Z
BruxZir Esthetic GL Single Unit Block - A1
BruxZir® Esthetic B4 GD 25mm Z
BruxZir® Esthetic White 16mm Z
BruxZir® Esthetic C4 GD 16mm Z
BruxZir® Esthetic C3 25mm Z
BruxZir® Esthetic B1 GD 25mm Z
BruxZir® Esthetic D2 GD 16mm Z
BruxZir® Esthetic Bleach 16mm Z
BruxZir® Esthetic B4 25mm Z
BruxZir® Esthetic C1 16mm Z
BruxZir® Esthetic A3 20mm Z
BruxZir Esthetic GL Single Unit Block - B2
BruxZir® Esthetic C4 GD 20mm Z
BruxZir® Esthetic B2 20mm Z
BruxZir® Esthetic White 14mm Z
BruxZir® Esthetic A3.5 25mm Z
BruxZir® Esthetic C3 20mm Z
BruxZir® Esthetic A1 16mm Z
BruxZir Esthetic GL Single Unit Block - White
BruxZir Esthetic GL Single Unit Block - C1
BruxZir® Esthetic Bleach 25mm Z
BruxZir® Esthetic D4 20mm Z
BruxZir® Esthetic A1 GD 14mm Z
BruxZir® Esthetic D3 20mm Z
BruxZir® Esthetic A1 GD 20mm Z
BruxZir® Esthetic D3 GD 20mm Z
BruxZir Esthetic GL Single Unit Block - D3
BruxZir Esthetic GL Single Unit Block - B3
BruxZir® Esthetic D4 GD 14mm Z
BruxZir® Esthetic B4 GD 14mm Z
BruxZir® Esthetic D2 GD 25mm Z
BruxZir® Esthetic A4 16mm Z
BruxZir® Esthetic Bleach GD 25mm Z
BruxZir Esthetic GL Single Unit Block - B4
BruxZir® Esthetic C4 25mm Z
BruxZir Esthetic GL Single Unit Block - A4
BruxZir® Esthetic White GD 14mm Z
BruxZir® Esthetic B4 16mm Z
BruxZir® Esthetic D2 16mm Z
BruxZir® Esthetic D3 GD 14mm Z
BruxZir® Esthetic D2 25mm Z
BruxZir® Esthetic A1 25mm Z
BruxZir® Esthetic A4 20mm Z
BruxZir® Esthetic A4 GD 16mm Z
BruxZir Esthetic GL Single Unit Block - C3
BruxZir® Esthetic B4 GD 16mm Z
BruxZir® Esthetic B3 GD 20mm Z
BruxZir® Esthetic C2 16mm Z
BruxZir Esthetic GL Single Unit Block - A3
BruxZir® Esthetic Bleach GD 14mm Z
BruxZir® Esthetic C1 GD 25mm Z
BruxZir® Esthetic D3 25mm Z
BruxZir® Esthetic C2 25mm Z
BruxZir® Esthetic C4 GD 14mm Z
BruxZir® Esthetic A1 12mm Z
BruxZir® Esthetic D4 25mm Z
BruxZir® Esthetic B3 GD 16mm Z
BruxZir® Esthetic White 20mm Z
BruxZir® Esthetic B1 GD 14mm Z
BruxZir® Esthetic D3 GD 16mm Z
BruxZir® Esthetic D2 20mm Z
BruxZir® Esthetic C3 16mm Z
BruxZir® Esthetic A3.5 20mm Z
BruxZir® Esthetic C2 20mm Z
BruxZir® Esthetic A3.5 GD 25mm Z
BruxZir® Esthetic A2 20mm Z
BruxZir Esthetic GL Single Unit Block - C4
BruxZir® Esthetic D4 16mm Z
BruxZir® Esthetic D4 GD 20mm Z
BruxZir® Esthetic A3.5 GD 14mm Z
BruxZir® Esthetic B1 20mm Z
BruxZir Esthetic GL Single Unit Block - C2
BruxZir® Esthetic A3 GD 14mm Z
BruxZir® Esthetic B2 GD 14mm Z
BruxZir® Esthetic A3.5 GD 16mm Z
BruxZir® Esthetic B3 25mm Z
BruxZir Esthetic GL Single Unit Block - D2
BruxZir® Esthetic B4 GD 20mm Z
BruxZir® Esthetic A4 25mm Z
BruxZir® Esthetic A3 GD 16mm Z
BruxZir® Esthetic D2 GD 14mm Z
BruxZir® Esthetic C2 GD 25mm Z
BruxZir® Esthetic C4 GD 25mm Z
BruxZir® Esthetic A4 GD 20mm Z
BruxZir® Esthetic A3 25mm Z
BruxZir® Esthetic A2 25mm Z
BruxZir® Esthetic B1 25mm Z
Establishment Types
Manufacture Medical Device
Complaint File Establishment per 21 CFR 820.198