Composite Buttons

Basic Information

• Brand Name: Composite Buttons
• Primary DI: 00190730002549
• Version / Model: OT-2344
• Company Name: ORTHO TECHNOLOGY, INC.
• Labeler DUNS: 781772017
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-24
• Public Version: 3
• Public Version Date: 2021-10-12
• Public Version Status: Update
• Public Device Record Key: 760482bd-0ce9-4d1d-9e7b-aa58e3ceb78e
• Distribution End Date: 2021-10-11

Device Description

Composite Buttons 10/pk

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: 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
Primary	00190730002549	GS1