Rotex / Rotex-RD / Dalbo®-Rotex

Basic Information

• Brand Name: Rotex / Rotex-RD / Dalbo®-Rotex
• Primary DI: 07640166514718
• Version / Model: 070380
• Catalog Number: 070380
• Company Name: Cendres+Métaux SA
• Labeler DUNS: 487506230
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-09-05
• Public Version: 1
• Public Version Date: 2022-09-13
• Public Version Status: New
• Public Device Record Key: 2a0bd3be-c35e-4da1-88c4-5cda070ddbe2

Device Description

Rotex / Rotex-RD / Dalbo®-Rotex Root canal drill (White) Anchor size 1

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: Yes
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• 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
EJL	Bur, Dental	Dental	872.3240	1

GMDN Terms

Code	Name	Definition	Implantable	Status
40529	Rotary/reciprocating endodontic file/rasp, reusable	A dental endpiece designed to be attached to a rotary or reciprocating dental power tool handpiece to debride and enlarge the root canal and smooth its walls by cutting or abrasion. It is made of metal [e.g., stainless steel, nickel-titanium alloy (Nitinol)] and its working end has a polygonal cross-section with edges. It may also be referred to as a rotary or engine file, or reamer. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07640166514718	GS1

Customer Contacts

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