Stabilok

Basic Information

• Brand Name: Stabilok
• Primary DI: 05060489370044
• Version / Model: Standard yellow
• Catalog Number: SY
• Company Name: FAIRFAX MEDICAL PRODUCTS LIMITED
• Labeler DUNS: 227221793
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 20
• 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: bcd5fcba-01cf-43fa-9437-63a55e75d63b

Device Description

Intended use to anchor a dentine pin in tooth dentine prior to building up the tooth. 20 single use pins + 1 reusable drill

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• 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	05060489370174	GS1
Primary	05060489370044	GS1

Device Sizes

Type	Value	Unit	Text
Outer Diameter	0.60	Millimeter