Propel

Basic Information

• Brand Name: Propel
• Primary DI: 00852673007066
• Version / Model: ASM-20022
• Catalog Number: ASM-20022
• Company Name: PROPEL ORTHODONTICS LLC
• Labeler DUNS: 117334253
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-03-06
• Public Version: 6
• Public Version Date: 2022-12-09
• Public Version Status: Update
• Public Device Record Key: c51dc8c1-db16-49de-a71c-2a45e013949c
• Distribution End Date: 2018-12-31

Device Description

Packaged Mouthpiece, Single, Assy

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: 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
ECR	Setter, Band, Orthodontic	Dental	872.4565	1

GMDN Terms

Code	Name	Definition	Implantable	Status
41678	Orthodontic appliance system, bonded	An assembly of custom-made and preformed devices such as metal bands, archwires, springs, screws, power arms and/or a base plate (framework), designed to be applied to the teeth to influence the shape and/or function of the stomatognathic system to correct malocclusions (e.g., underbites, overbites, cross bites, open bites, crooked teeth) and/or other cosmetic and/or structural flaws of teeth and/or jaws. Often referred to as dental braces, it is intended to remain in the oral cavity for the duration of the treatment, and may be periodically adjusted by an orthodontist to effect skeletal and/or dental changes. This is a single-use device.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00852673007066	GS1

Customer Contacts

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