NEWGEAR

Basic Information

• Brand Name: NEWGEAR
• Primary DI: D80723400031
• Version / Model: 23-400-03
• Catalog Number: 23-400-03
• Company Name: DENTSPLY SIRONA ORTHODONTICS INC.
• Labeler DUNS: 116903307
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-06-26
• Public Version: 5
• Public Version Date: 2021-12-23
• Public Version Status: Update
• Public Device Record Key: 91e02e2b-b60e-44b7-9413-ea1863928884
• Distribution End Date: 2020-12-31

Device Description

NEWGEAR HIGHPULL KIT-RED

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: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: Yes
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• 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
DZB	Headgear, extraoral, orthodontic	Dental	872.5500	2

GMDN Terms

Code	Name	Definition	Implantable	Status
31757	Orthodontic extraoral headgear	A dental device used in conjunction with orthodontic appliances to exert pressure on the teeth or the jaws from outside the mouth. An orthodontic headgear will typically have a strap that wraps around the patient's neck or head and an inner bow portion that is fastened to the orthodontic appliance in the patient's mouth, or utilizes rests on the chin and forehead (reverse pull headgear).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	D80723400031	HIBCC

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K940410	000