FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Telio Lab
DI: DIVO628054EN1
·
Model: 628054EN
·
IVOCLAR VIVADENT AKTIENGESELLSCHAFT
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Telio Lab
- Primary DI
- DIVO628054EN1
- Version / Model
- 628054EN
- Catalog Number
- 628054EN
- 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
- 2
- Public Version Date
- 2021-03-23
- Public Version Status
- Update
- Public Device Record Key
- 7635529e-9528-4d9d-90bf-5f3c3c82b09c
- Distribution End Date
- 2021-03-23
Device Description
Telio Lab Cold Liquid OP0, OP1, Telio Lab Opaquer Liquid OP2, Telio Lab Opaquer BL3, A1, A2, A3, Telio Lab Dentin A3.5, B1, I1, I2, I3, N1, N2, N3, Telio Lab Incisal, Telio Lab Neck, SR Separating Fluid
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 |
|---|---|---|---|---|
| 38781 | Dental prosthesis veneer resin | A dental resin composite material intended to be used for veneering a restorative dental prosthesis (e.g., crown, bridge, fixed or removable denture); some types may be used as stains to apply colour to the dental appliance. After application, this material cannot be reused. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | DIVO628054EN1 | HIBCC |