FDA UDI In Commercial Distribution 🇺🇸 United States

IPS e.max ZirCAD

DI: DIVO688616EN1 · Model: 688616EN · IVOCLAR VIVADENT AKTIENGESELLSCHAFT
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
IPS e.max ZirCAD
Primary DI
DIVO688616EN1
Version / Model
688616EN
Catalog Number
688616EN
Company Name
IVOCLAR VIVADENT AKTIENGESELLSCHAFT
Labeler DUNS
448015938
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2018-09-27
Public Version
1
Public Version Date
2018-10-29
Public Version Status
New
Public Device Record Key
f469ac61-5f92-44e4-894a-f1273dba7174

Device Description

IPS e.max ZirCAD LT 1 98.5-16mm/1, IPS e.max ZirCAD MT A2 98.5-14mm/1, IPS e.max ZirCAD MT Multi A2 98.5-16mm/1, IPS Ivocolor Shade Dentin SD2, Incisal Sl2, Glaze Paste FLUO, IPS Ivocolor Mixing Liquid allround

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
EIH POWDER, PORCELAIN

GMDN Terms

Code Name
16187 Dental appliance fabrication material, ceramic

Identifiers

Type ID
Primary DIVO688616EN1