InBrace Teeth Straightening System (Gen 2.0)

Basic Information

• Brand Name: InBrace Teeth Straightening System (Gen 2.0)
• Primary DI: 00850018135054
• Version / Model: Lower Fitting Kit
• Catalog Number: 85003
• Company Name: SWIFT HEALTH SYSTEMS INC.
• Labeler DUNS: 884398210
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-11-07
• Public Version: 2
• Public Version Date: 2022-10-04
• Public Version Status: Update
• Public Device Record Key: b15e1541-b71c-4949-b462-b5f881efac5b

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: No
• 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
PNN	Orthodontic Software	Dental	872.5470	2

GMDN Terms

Code	Name	Definition	Implantable	Status
64010	Orthodontic appliance/positioning tray kit	A collection of dental devices which includes a custom-made positioning tray (indirect bonding tray) intended to position and hold in place a set of included orthodontic appliances (e.g., brackets, buccal tubes, lingual retainers) to bond them to teeth during a single procedure. The components are typically made of synthetic polymer and/or metal materials and include appliances manufactured from an oral cavity impression or oral scan for a specific patient (custom-made). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00850018135054	GS1