N/A

Basic Information

• Brand Name: N/A
• Primary DI: D746ART01R1
• Version / Model: ART01-R
• Catalog Number: ART01-R
• Company Name: DENTSPLY SIRONA ORTHODONTICS INC.
• Labeler DUNS: 116903307
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-12-16
• Public Version: 3
• Public Version Date: 2024-03-01
• Public Version Status: Update
• Public Device Record Key: 9998a10a-da3f-48ae-9219-f8769e0cac5a

Device Description

Appliance Remover Tool - Retail

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• 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: 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: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
EIY	Instrument, Filling, Plastic, Dental	Dental	872.4565	1

GMDN Terms

Code	Name	Definition	Implantable	Status
63677	Orthodontic appliance remover	A small hook-shaped device designed for manual removal of orthodontic devices (e.g., retainer, teeth positioner) from around the teeth. It is made of plastic materials. This is a single-patient, reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	D746ART01R1	HIBCC

Customer Contacts

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