FDA UDI In Commercial Distribution 🇺🇸 United States

ORTHO-JET TINTING CONCENTRATE LIQUID

DI: D6503306YEL0 · Model: 946 ML YELLOW · LANG DENTAL MANUFACTURING CO., INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
ORTHO-JET TINTING CONCENTRATE LIQUID
Primary DI
D6503306YEL0
Version / Model
946 ML YELLOW
Catalog Number
3306YEL
Company Name
LANG DENTAL MANUFACTURING CO., INC.
Labeler DUNS
005185798
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2017-12-01
Public Version
2
Public Version Date
2018-03-29
Public Version Status
Update
Public Device Record Key
d80edfdd-bd1b-45d8-82ea-6870385c308b

Device Description

DYE FOR ACRYLIC RESIN LIQUID

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
Yes
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
EBI Resin, Denture, Relining, Repairing, Rebasing

GMDN Terms

Code Name
16727 Dental prosthesis restorative material, unfilled resin

Identifiers

Type ID
Primary D6503306YEL0