FDA UDI
In Commercial Distribution
🇺🇸 United States
Tizian Blank NEM, 98 x 18 mm
DI: ESDG2201031
·
Model: 220103
·
Schütz Dental GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Tizian Blank NEM, 98 x 18 mm
- Primary DI
- ESDG2201031
- Version / Model
- 220103
- Company Name
- Schütz Dental GmbH
- Labeler DUNS
- 315830349
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-11-08
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- 843ddc99-b4af-4f06-9864-4dc6d58d9c4f
Device Description
Shape 98 mm, round The CoCr round blank for milling crowns, bridges and bars. With a Vickers hardness of 320 HV, this CoCr material can be milled and polished very well. Naturally, the material is free from beryllium and nickel.
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
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- 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 |
|---|---|---|---|---|
| EJH | Alloy, Metal, Base | Dental | 872.3710 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35857 | Dental casting non-noble alloy | A material composed primarily of non-noble metals [e.g., includes alloys such as cobalt-chrome (Co-Cr), nickel-chromium, titanium (Ti)] intended for use in the fabrication of a dental cast [i.e., a positive copy of a part of the oral anatomy made in an impression (mould), such as a dental crown] or dental restorations and appliances (e.g., porcelain-fused-to-metal crowns and bridge restorations). It is typically available in the form of small ingots or bars that are melted and poured into an impression. After application, this device cannot be reused. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | ESDG2201031 | HIBCC |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store blanks in a dry place