Pedo OnBrace Crown UR6 (5/pk)

Basic Information

• Brand Name: Pedo OnBrace Crown UR6 (5/pk)
• Primary DI: D8199013990
• Version / Model: 901399
• 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: 2
• Public Version Date: 2024-12-06
• Public Version Status: Update
• Public Device Record Key: 3f312e04-ec75-4fbe-9a98-a0b8beb2c57b

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
ECM	Band, Preformed, Orthodontic	Dental	872.5410	1

GMDN Terms

Code	Name	Definition	Implantable	Status
38734	Orthodontic metal band	A thin metal ring designed to be fitted around the contours of a tooth and cemented into place to support an orthodontic attachment (e.g., bracket, tube), brazed or soldered onto the ring, intended to be secured to the tooth. This is a single-patient device intended to be used for the duration of the treatment (single-use) before being discarded.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	D8199013992	HIBCC		5	In Commercial Distribution
Primary	D8199013990	HIBCC