BIOFORCE®

Basic Information

• Brand Name: BIOFORCE®
• Primary DI: D807026285831
• Version / Model: 02-628-583
• Catalog Number: 02-628-583
• Company Name: DENTSPLY SIRONA ORTHODONTICS INC.
• Labeler DUNS: 116903307
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2020-09-24
• Public Version: 2
• Public Version Date: 2021-12-23
• Public Version Status: Update
• Public Device Record Key: 44aa46c6-a9ee-46b2-9b83-d487315e5013
• Distribution End Date: 2020-12-31

Device Description

BIOFORCE® 21X28 LOWER ACCU-FORM® LARGE IG

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: Yes
• 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
DZC	WIRE, ORTHODONTIC	Dental	872.5410	1

GMDN Terms

Code	Name	Definition	Implantable	Status
41397	Orthodontic archwire	A dental wire in the shape of an arch used with orthodontic attachments (orthodontic brackets) that are affixed to the crowns/surfaces of two or more teeth in order to cause/guide tooth movement. 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
Unit of Use	D807026285830	HIBCC
Primary	D807026285831	HIBCC

Customer Contacts

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