CONTEMPORARY ORTHO-JET LIQUID

Basic Information

• Brand Name: CONTEMPORARY ORTHO-JET LIQUID
• Primary DI: D6501508GRN0
• Version / Model: 19 L GREEN
• Catalog Number: 1508GRN
• 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: a08a49a1-7845-402b-80c6-ea57670a984a

Device Description

FAST CURING ORTHODONTIC 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	Medical Specialty	Regulation #	Device Class
EBI	Resin, Denture, Relining, Repairing, Rebasing	Dental	872.3760	2

GMDN Terms

Code	Name	Definition	Implantable	Status
16727	Dental prosthesis restorative material, unfilled resin	A material designed to repair dental prostheses that consists of an unfilled polymeric resin. The material works as a bonding agent to provide a strong and long-lasting attachment to the segments of a broken or cracked prosthesis; it typically consists of a single or two-component polymeric (e.g., acrylic) resin that usually becomes a solid polymer when treated with light and/or heat. The material is used in a dentist?s office or dental laboratory to repair fixed dental prostheses and/or partial or total dentures.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	D6501508GRN0	HIBCC