Trefoil™

Basic Information

• Brand Name: Trefoil™
• Primary DI: 07332747105155
• Version / Model: 38335
• Catalog Number: 38335
• Company Name: Nobel Biocare AB
• Labeler DUNS: 353939929
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-04-06
• Public Version: 8
• Public Version Date: 2022-09-16
• Public Version Status: Update
• Public Device Record Key: 331b681b-0344-4fc4-99fa-943d71f4066e

Device Description

Twist Drill Trefoil™ 3x11.5-13mm

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: 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: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
DZI	Drill, Bone, Powered	Dental	872.4120	2

GMDN Terms

Code	Name	Definition	Implantable	Status
45697	Fixture/appliance dental drill bit, single-use	A shaft of metal intended to be used in dental surgery to create channels of appropriate depth and diameter in bone (osteotomy) of the oral cavity to facilitate the implantation of a dental fixture/appliance. The device is typically available in a set of graduated sizes and various forms and functions (e.g., guide, pilot, twist, cortical, conical). It is attached to a motorized handpiece or other power source that provides rotation. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07332747105155	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Length	13.000	Millimeter
Outer Diameter	3.000	Millimeter