OnBrace Kit w/ Archwire Tubes

Basic Information

• Brand Name: OnBrace Kit w/ Archwire Tubes
• Primary DI: D8199013480
• Version / Model: 901348
• Company Name: SPECIALTY APPLIANCES, LLC
• Labeler DUNS: 106645484
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-09-24
• Public Version: 1
• Public Version Date: 2024-10-02
• Public Version Status: New
• Public Device Record Key: 7ad625b3-57a4-45e0-9fb4-8c1b49609c2c

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: 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
ELZ	Crown, Preformed	Dental	872.3330	1

GMDN Terms

Code	Name	Definition	Implantable	Status
34976	Preformed dental crown, temporary	A prefabricated tooth crown, usually made of stainless steel, aluminium (Al) or resin, that is designed to be fitted over a damaged or prepared tooth of a baby/child (primary tooth) or post-pubescent/adult patient (permanent tooth) to serve as a temporary device, typically until the natural tooth falls out or until the fitting of a permanent crown (not included). This device is commonly used during prosthodontic treatment or other restorative work required as a result of traumatic injury.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	D8199013480	HIBCC