GRADIA®

Basic Information

• Brand Name: GRADIA®
• Primary DI: D0470019891
• Version / Model: 001989
• Catalog Number: 001989
• Company Name: Gc America Inc.
• Labeler DUNS: 005473608
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-08-01
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 3d1f30ae-cd61-4829-9176-1037ecd52664

Device Description

GRADIA® DIRECT Syringes: 1 syringe (2.7mL) A2

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
EBF	MATERIAL, TOOTH SHADE, RESIN	Dental	872.3690	2

GMDN Terms

Code	Name	Definition	Implantable	Status
38764	Light-cured dental restorative composite resin	A dental restorative material that consists of a blend of filler particles (e.g., glass, ceramic, zirconia, silica) mixed with a synthetic, photo-polymerizable, organic resin matrix [e.g., bisphenol A-glycidyl methacrylate (BISGMA), urethane dimethacrylate (UDMA)] intended to fill dental cavities or restore damaged hard dental tissue. It is typically a one-part paste, contained within an application syringe or capsule, that requires a light source of specific wavelengths (e.g., 460 to 480 nm) to initiate resin polymerization/hardening post application; it is typically available in tooth-coloured shades. After application, this device cannot be reused.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	D0470019891	HIBCC

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K023814	000

Device Sizes

Type	Value	Unit	Text
Total Volume	2.4	Milliliter

Storage Conditions

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