Protraction Facemask

Basic Information

• Brand Name: Protraction Facemask
• Primary DI: 00190746057946
• Version / Model: 852-800
• Catalog Number: 852-800
• Company Name: AMERICAN ORTHODONTICS CORPORATION
• Labeler DUNS: 044668515
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-05-19
• Public Version: 2
• Public Version Date: 2022-10-28
• Public Version Status: Update
• Public Device Record Key: 2fbdfe59-0b25-4bd2-b2c9-41d25c95be75
• Distribution End Date: 2022-10-27

Device Description

PROTRACTION FACE MASK

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: 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
DZB	Headgear, extraoral, orthodontic	Dental	872.5500	2

GMDN Terms

Code	Name	Definition	Implantable	Status
41067	Orthodontic chin cap/cup	A dental device component of an extraoral orthodontic headgear designed to help reduce/correct mandibular prognathism by applying reverse pull force to the chin, via tight attachment to the headgear head straps. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00190746057946	GS1

Customer Contacts

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