FDA UDI Not in Commercial Distribution 🇺🇸 United States

IPS e.max CAD

DI: DIVO6053851 · Model: 605385 · IVOCLAR VIVADENT AKTIENGESELLSCHAFT
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
5

Basic Information

Brand Name
IPS e.max CAD
Primary DI
DIVO6053851
Version / Model
605385
Catalog Number
605385
Company Name
IVOCLAR VIVADENT AKTIENGESELLSCHAFT
Labeler DUNS
448015938
Distribution Status
Not in Commercial Distribution
Device Count in Pkg
5
Record Status
Published
Publish Date
2016-11-28
Public Version
4
Public Version Date
2018-12-14
Public Version Status
Update
Public Device Record Key
1741b5b0-0f61-4545-b4b1-897222b0d9ba
Distribution End Date
2018-12-12

Device Description

materials for inlays, onlays, crowns and bridges

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
No
Has Expiration Date
No
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 DIVO6053851
Unit of Use DIVO6053850