FDA UDI
In Commercial Distribution
🇺🇸 United States
inCoris TZI Coloring Liquid
DI: E27663395060
·
Model: 6339506
·
SIRONA Dental Systems GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- inCoris TZI Coloring Liquid
- Primary DI
- E27663395060
- Version / Model
- 6339506
- Company Name
- SIRONA Dental Systems GmbH
- Labeler DUNS
- 340306351
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-10
- Public Version
- 6
- Public Version Date
- 2022-05-17
- Public Version Status
- Update
- Public Device Record Key
- abb90997-6d54-4ac6-9855-b95f28b10b1b
Device Description
inCoris TZI Starter Kit Coloring Liquids consists of 1 pcs of: E27663395220 E27663395480 E27663395630 E27663395890 E27663396050 E27663396210 E27663396470 E27663396620 E27663396880 E27663397040 E27663397200 E27663397460 E27663397610 E27663397870 E27663398030 E27663398290
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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
- No
- Has Manufacturing Date
- No
- 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 | E27663395060 | HIBCC |
Customer Contacts
- Phone
- +4962511670
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 4 – 22 Degrees Celsius