FDA UDI Not in Commercial Distribution 🇺🇸 United States

IPS e.max Press

DI: DVIV626300EN1 · Model: 626300EN · IVOCLAR VIVADENT AKTIENGESELLSCHAFT
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
50

Basic Information

Brand Name
IPS e.max Press
Primary DI
DVIV626300EN1
Version / Model
626300EN
Catalog Number
626300EN
Company Name
IVOCLAR VIVADENT AKTIENGESELLSCHAFT
Labeler DUNS
448015938
Distribution Status
Not in Commercial Distribution
Device Count in Pkg
50
Record Status
Published
Publish Date
2020-11-11
Public Version
2
Public Version Date
2022-01-28
Public Version Status
Update
Public Device Record Key
007fba69-9bf4-4efb-98c5-bc62ebcaf9eb
Distribution End Date
2022-01-27

Device Description

IPS e.max Press HO 1 5 pcs, IPS e.max Press MO 1 5 pcs, IPS e.max Press LT A1 5 pcs., IPS e.max Press LT A2 5 pcs., IPS e.max Press LT A3 5 pcs., IPS e.max Press LT B1 5 pcs., IPS e.max Press HT A1 5 pcs, IPS e.max Press HT A2 5 pcs, IPS e.max Press HT A3 5 pcs, IPS e.max Press HT B1 5 pcs

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
44879 Dental implant suprastructure, permanent, preformed

Identifiers

Type ID
Unit of Use DVIV626300EN0
Primary DVIV626300EN1