FDA UDI In Commercial Distribution 🇺🇸 United States

CONTEMPORARY ORTHO-JET POWDER

DI: D6501550BLU0 · Model: 2.3 KG BLUE · LANG DENTAL MANUFACTURING CO., INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
CONTEMPORARY ORTHO-JET POWDER
Primary DI
D6501550BLU0
Version / Model
2.3 KG BLUE
Catalog Number
1550BLU
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
31eeb1f2-063c-417f-822d-c7dae3209274

Device Description

FAST CURING ORTHODONTIC ACRYLIC RESIN POWDER

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 D6501550BLU0