Build-It FR

Basic Information

• Brand Name: Build-It FR
• Primary DI: 00814978021345
• Version / Model: N32FSB
• Company Name: Kerr Corporation
• Labeler DUNS: 199354556
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-08-01
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: cd5a393e-a1cf-488f-b4c5-dde7d88962f0

Device Description

Core Material; Syringe with 5 Mixing/Intra-oral Tips; Gold; Refill

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
16725	Self-cured dental restorative composite resin	A dental restorative material consisting of a blend of glass or ceramic particles dispersed in a synthetic, self-polymerizable, organic resin matrix that is typically used to fill dental cavities or restore damaged dental tissue. It is typically a two-paste system (self-cured when put together) consisting basically of a dimethacrylate resin [(e.g., a bisphenol A and glycidylmethacrylate (BIS-GMA)]; the filler is usually made of glass, quartz, or ceramic. Typically, one paste contains an accelerator and the other a catalyst which polymerize a solid resin. This single-use product should match the colour of the original teeth for aesthetic reasons.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00814978021345	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Total Volume	4	Milliliter

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 2 – 8 Degrees Celsius