SCOTT'S SELECT GATES DRILLS 6/pk 28mm # 4

Basic Information

• Brand Name: SCOTT'S SELECT GATES DRILLS 6/pk 28mm # 4
• Primary DI: D77811253441
• Version / Model: 112-5344
• Catalog Number: 112-5344
• Company Name: SCOTT'S DENTAL SUPPLY L.L.C.
• Labeler DUNS: 137217043
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 6
• Record Status: Published
• Publish Date: 2021-02-27
• Public Version: 1
• Public Version Date: 2021-03-08
• Public Version Status: New
• Public Device Record Key: 30104e24-2e52-4f71-bccd-56fa2018398a

Device Description

GATES DRILLS (6/pack) Length: 28mm, Size: 4, Material: Stainless Steel; For more information: https://www.scottsdental.com/catalog/product/view/id/23532/s/gates-glidden-drills-scott-s-select/

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• 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
DZA	DRILL, DENTAL, INTRAORAL	Dental	872.4130	1

GMDN Terms

Code	Name	Definition	Implantable	Status
43311	Pin/post dental drill bit	A shaft of metal, typically with a spiralled portion at the cutting end (a twist drill bit), intended to be attached to a motorized handpiece, or other power source, to create a precise round hole at the appropriate depth in teeth or bone of the oral cavity. This hole or slot is used to secure cast or preformed pins/posts for stabilizing and retaining operative dental appliances. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	D77811253440	HIBCC
Primary	D77811253441	HIBCC

Customer Contacts

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