FDA UDI In Commercial Distribution 🇺🇸 United States

IPS e.max Ceram

DI: 07615208374100 · Model: 605489 · IVOCLAR VIVADENT AKTIENGESELLSCHAFT
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1

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Basic Information

Brand Name
IPS e.max Ceram
Primary DI
07615208374100
Version / Model
605489
Catalog Number
605489
Company Name
IVOCLAR VIVADENT AKTIENGESELLSCHAFT
Labeler DUNS
448015938
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2025-07-10
Public Version
1
Public Version Date
2025-07-18
Public Version Status
New
Public Device Record Key
857b3240-d8fd-4801-92a1-07f2b1480838

Device Description

IPS e.max Ceram Intensive Gingiva 20 g 3

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
Yes
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
Previous DIVO6054891
Primary 07615208374100