OFA Coloring Liquid

Basic Information

• Brand Name: OFA Coloring Liquid
• Primary DI: D791CLOFAKIT0
• Version / Model: CL-OFA-KIT
• Catalog Number: CL-OFA-KIT
• Company Name: TALLADIUM, INC.
• Labeler DUNS: 094430642
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-02-20
• Public Version: 1
• Public Version Date: 2019-03-11
• Public Version Status: New
• Public Device Record Key: 6f26418b-8678-4728-8cad-c0f3a95b989b

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• 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: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
EIH	Powder, Porcelain	Dental	872.6660	2

GMDN Terms

Code	Name	Definition	Implantable	Status
62110	Dental prosthesis dye	A colouring intended to be used to stain a dental prosthesis (e.g., crown, bridge) before insertion in the patient to achieve a colour to match existing dentition. It is a mixture of inorganic chemicals typically used during the prosthesis manufacturing process. After application, this device cannot be reused.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	D791CLOFAKIT0	HIBCC

Premarket Submissions

Submission Number	Supplement Number
K143090	000