FDA UDI
In Commercial Distribution
🇺🇸 United States
SINTERNIT 106H18
DI: D800MEAS10618
·
Model: MEAS10618
·
ZIRKONZAHN SRL
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- SINTERNIT 106H18
- Primary DI
- D800MEAS10618
- Version / Model
- MEAS10618
- Company Name
- ZIRKONZAHN SRL
- Labeler DUNS
- 564251911
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-07-20
- Public Version
- 1
- Public Version Date
- 2022-07-28
- Public Version Status
- New
- Public Device Record Key
- d0dee0da-1b18-4d11-9df5-95552bf98526
Device Description
Content: 1 piece Height: 18 mm Sinternit (cobalt-chrome alloy) for the production of single crowns, bridges, bars and telescopic crowns. It is suitable for monolithic restorations as well as structures of up to 14 units for veneering with ceramics. Info: our Sintermetall has a new name: Sinternit. Properties and range of applications remain unchanged
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
- 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 |
|---|---|---|---|---|
| EJH | ALLOY, METAL, BASE | Dental | 872.3710 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 38614 | Dental bridge, metal-ceramic | A custom-made, non-removable, artificial replacement for one or more missing teeth made of metal alloy combined with tooth-coloured ceramic material (veneer), and comprised of an artifical tooth/teeth and crowns. It is fixed to abutment/adjacent teeth, tooth roots, or dental implants. Also referred to as a fixed partial prosthesis or a fixed partial denture. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | D800MEAS10618 | HIBCC |
Customer Contacts
- Phone
- +390474066660
- [email protected]