UNIFAST™

Basic Information

• Brand Name: UNIFAST™
• Primary DI: 10386040000987
• Version / Model: 339291
• Catalog Number: 339291
• Company Name: Gc America Inc.
• Labeler DUNS: 005473608
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-07-07
• Public Version: 1
• Public Version Date: 2022-07-15
• Public Version Status: New
• Public Device Record Key: d8e95a64-e840-4ec2-9041-0e2e3cd3ef2e

Device Description

UNIFAST™ Trad 104mL liquid

Device Characteristics

• Single Use: No
• 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: 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
EBG	CROWN AND BRIDGE, TEMPORARY, RESIN	Dental	872.3770	2

GMDN Terms

Code	Name	Definition	Implantable	Status
45236	Temporary dental crown/bridge resin	A material [e.g., polymethylmethacrylate (PMMA)] intended to make a temporary crown or bridge prosthesis for use until a permanent restoration is fabricated.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20386040000984	GS1	Carton	10	In Commercial Distribution
Primary	10386040000987	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K984365	000

Device Sizes

Type	Value	Unit	Text
Total Volume	104	Milliliter

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 39 – 77 Degrees Fahrenheit
• Type: Storage Environment Temperature
• Temperature Range: 4 – 25 Degrees Celsius