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
EBG CROWN AND BRIDGE, TEMPORARY, RESIN

GMDN Terms

Code Name
38781 Dental prosthesis veneer resin

Identifiers

Type ID
Primary DIVO628054EN1