FDA UDI
In Commercial Distribution
🇺🇸 United States
Stain Colour 3D Base A (1 g)
DI: D800MFAC1601
·
Model: MFAC1601
·
ZIRKONZAHN SRL
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Stain Colour 3D Base A (1 g)
- Primary DI
- D800MFAC1601
- Version / Model
- MFAC1601
- Company Name
- ZIRKONZAHN SRL
- Labeler DUNS
- 564251911
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-11-04
- Public Version
- 3
- Public Version Date
- 2018-07-24
- Public Version Status
- Update
- Public Device Record Key
- d0b26f1b-bea9-4a6e-979e-04069c1606f7
Device Description
Content: 1 g Three-dimensional stain colours with special depth effect for surface colouring of full zirconia, ceramics and press ceramic. Stain and glaze firing can also be done in one step by working with the glazing mass directly on the case.
Device Characteristics
- Single Use
- No
- 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 |
|---|---|---|---|---|
| 16187 | Dental appliance fabrication material, ceramic | A dental material made of ceramic materials (e.g., zirconium oxide) 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 | D800MFAC1601 | HIBCC |
Customer Contacts
- Phone
- +390474066660
- [email protected]