FDA UDI Not in Commercial Distribution 🇺🇸 United States

Telio CS Inlay Telio CS Onlay

DI: DVIV635337AN1 · Model: 635337AN · IVOCLAR VIVADENT AKTIENGESELLSCHAFT
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
30

Basic Information

Brand Name
Telio CS Inlay Telio CS Onlay
Primary DI
DVIV635337AN1
Version / Model
635337AN
Catalog Number
635337AN
Company Name
IVOCLAR VIVADENT AKTIENGESELLSCHAFT
Labeler DUNS
448015938
Distribution Status
Not in Commercial Distribution
Device Count in Pkg
30
Record Status
Published
Publish Date
2016-12-14
Public Version
4
Public Version Date
2022-07-21
Public Version Status
Update
Public Device Record Key
90f10e50-4b43-49cb-a75a-88df652497b7
Distribution End Date
2022-07-20

Device Description

Telio CS Onlay Refill 30x0.25g Universal

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
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
Yes
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
EMA CEMENT, DENTAL

GMDN Terms

Code Name
35870 Dental composite resin

Identifiers

Type ID
Primary DVIV635337AN1
Unit of Use DVIV635337AN0