Stabilok

Basic Information

• Brand Name: Stabilok
• Primary DI: 05060489370037
• Version / Model: Economy Green
• Catalog Number: JG
• Company Name: FAIRFAX MEDICAL PRODUCTS LIMITED
• Labeler DUNS: 227221793
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 100
• Record Status: Published
• Publish Date: 2023-04-16
• Public Version: 1
• Public Version Date: 2023-04-24
• Public Version Status: New
• Public Device Record Key: 0dfaf766-0a69-4e3e-bac9-e8778c96c0b6

Device Description

Intended use to anchor a dentine pin in tooth dentine prior to building up the tooth. 100 single use pins + 5 reusable drills

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: Yes
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
EBL	Pin, Retentive And Splinting, And Accessory Instruments	Dental	872.3740	1

GMDN Terms

Code	Name	Definition	Implantable	Status
35868	Dental restoration retention pin	A device intended to be placed permanently in the tooth to provide retention and/or stabilization for a dental restoration (e.g., a filling or a crown). It is typically made of stainless steel or titanium (Ti) and comes in a variety of sizes (e.g., 1.0 mm to 3.2 mm). The device is inserted into a pre-drilled hole in the tooth and is secured by threading, friction and/or cementing.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	05060489370198	GS1
Primary	05060489370037	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Outer Diameter	0.76	Millimeter