FDA UDI Not in Commercial Distribution 🇺🇸 United States

e.max Ceram

DI: DIVO681629EN1 · Model: 681629EN · IVOCLAR VIVADENT AKTIENGESELLSCHAFT
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
e.max Ceram
Primary DI
DIVO681629EN1
Version / Model
681629EN
Catalog Number
681629EN
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
3
Public Version Date
2022-02-11
Public Version Status
Update
Public Device Record Key
9b3ebfd9-d47f-46d0-b393-94b3b6c8bc59
Distribution End Date
2022-02-10

Device Description

IPS e.max Ceram Power Dentin A2, Power Incisal 1, IPS Build-Up Liquid allround, Ivocolor Shade Dentin SD1, Ivocolor Shade Incisal SI3, Ivocolor Essence E 04 sunset, Ivocolor Essence E 10 mahogany, Ivocolor Glaze Powder FLUO, Ivocolor Glaze Paste FLUO, 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 DIVO681629EN1