FDA UDI
In Commercial Distribution
🇺🇸 United States
Telio CAD
DI: 07615208343045
·
Model: 665623
·
IVOCLAR VIVADENT AKTIENGESELLSCHAFT
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
9
Basic Information
- Brand Name
- Telio CAD
- Primary DI
- 07615208343045
- Version / Model
- 665623
- Catalog Number
- 665623
- Company Name
- IVOCLAR VIVADENT AKTIENGESELLSCHAFT
- Labeler DUNS
- 448015938
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 9
- Record Status
- Published
- Publish Date
- 2025-11-26
- Public Version
- 1
- Public Version Date
- 2025-12-04
- Public Version Status
- New
- Public Device Record Key
- a97f8775-1f8d-49fb-b1fb-4bf3228dbf20
Device Description
Telio CAD PlanMill LT B1 B40L/9
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
- 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 |
|---|---|---|---|---|
| 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 |
|---|---|---|---|---|---|---|
| Unit of Use | 07615208583724 | GS1 | ||||
| Primary | 07615208343045 | GS1 | ||||
| Previous | DIVO6656231 | HIBCC |