FDA UDI In Commercial Distribution 🇺🇸 United States

CZR PRESS LF ESTHETIC WHITE LAYERING KIT

DI: EKUR1070140KA0 · Model: 107-0140KA · KURARAY NORITAKE DENTAL INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
CZR PRESS LF ESTHETIC WHITE LAYERING KIT
Primary DI
EKUR1070140KA0
Version / Model
107-0140KA
Company Name
KURARAY NORITAKE DENTAL INC.
Labeler DUNS
697119498
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2017-02-17
Public Version
4
Public Version Date
2021-08-10
Public Version Status
Update
Public Device Record Key
b3d40615-e3a4-4e13-bdd4-370a4071b34b

Device Description

89g

Device Characteristics

Single Use
No
Prescription Use (Rx)
Yes
Over the Counter (OTC)
No
Kit
Yes
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 EKUR1070140KA0