OrthoFlex™

Basic Information

• Brand Name: OrthoFlex™
• Primary DI: 00190707106270
• Version / Model: COM-121
• Company Name: Ortho Organizers, Inc.
• Labeler DUNS: 062165188
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2025-09-26
• Public Version: 3
• Public Version Date: 2025-12-30
• Public Version Status: Update
• Public Device Record Key: d0070b41-35e5-49d7-9968-c5ea6f6edb4a

Device Description

OrthoFlex™ Composite .022 UR3 Hk Roth Rx 0° Tor. +11° Ang.(10PK)

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
DYW	BRACKET, PLASTIC, ORTHODONTIC	Dental	872.5470	2

GMDN Terms

Code	Name	Definition	Implantable	Status
46582	Orthodontic bracket, plastic, single-use	A plastic device intended to be bonded to a tooth, to hold an orthodontic wire and/or other appliance (e.g., rubber bands) used to apply pressure to the tooth in order to alter the position of 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
Unit of Use	10190707106277	GS1
Primary	00190707106270	GS1

Premarket Submissions

Submission Number	Supplement Number
K973776	000