FDA UDI
In Commercial Distribution
🇺🇸 United States
Vita CAD-Temp For Inlab
DI: 07630031744524
·
Model: Bridges (tooth borne)
·
Institut Straumann AG
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Vita CAD-Temp For Inlab
- Primary DI
- 07630031744524
- Version / Model
- Bridges (tooth borne)
- Catalog Number
- 010.4059
- Company Name
- Institut Straumann AG
- Labeler DUNS
- 483599259
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-07-23
- Public Version
- 2
- Public Version Date
- 2023-10-25
- Public Version Status
- Update
- Public Device Record Key
- c9ff25ed-389f-4615-8256-731566d061ea
Device Description
CARES® 9-unit restoration, VITA® CAD-Temp® , multiColor xSHADEx
Device Characteristics
- Single Use
- Yes
- 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
- MR Conditional
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| EBG | CROWN AND BRIDGE, TEMPORARY, RESIN | Dental | 872.3770 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 37542 | Dental bridge, polymer | A custom-made, non-removable, artificial replacement for one or more missing teeth made entirely of polymer-based material, with or without fibre reinforcement, 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 | 07630031744524 | GS1 |
Customer Contacts
- Phone
- +1(801)448-8168
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K070991 | 000 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep away from sunlight