FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Telio CAD
DI: DIVO690298AN1
·
Model: 690298AN
·
IVOCLAR VIVADENT AKTIENGESELLSCHAFT
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Telio CAD
- Primary DI
- DIVO690298AN1
- Version / Model
- 690298AN
- Catalog Number
- 690298AN
- Company Name
- IVOCLAR VIVADENT AKTIENGESELLSCHAFT
- Labeler DUNS
- 448015938
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-09-27
- Public Version
- 4
- Public Version Date
- 2022-02-07
- Public Version Status
- Update
- Public Device Record Key
- fae4078b-75f3-4a6e-9d23-8ca9f733861a
- Distribution End Date
- 2022-02-04
Device Description
Telio CAD Disc, Colado CAD CoCr4 Disc, IPS e.max ZirCAD Multi Disc, SR Vivodent CAD Disc, ProArt CAD Model Disc, IvoBase CAD Disc, ProArt CAD Splint Disc, ProArt CAD Try-In Disc, ProArt CAD Wax yellow Disc, IvoBase CAD Bond Monomer, IvoBase CAD Bond Polymer, var. accessories
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
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
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 |
|---|---|---|---|---|
| 45236 | Temporary dental crown/bridge resin | A material [e.g., polymethylmethacrylate (PMMA)] intended to make a temporary crown or bridge prosthesis for use until a permanent restoration is fabricated. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | DIVO690298AN1 | HIBCC |