Buttons

Basic Information

• Brand Name: Buttons
• Primary DI: 00190746151804
• Version / Model: 294-170PK
• Catalog Number: 294-170PK
• Company Name: AMERICAN ORTHODONTICS CORPORATION
• Labeler DUNS: 044668515
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-03-16
• Public Version: 2
• Public Version Date: 2021-03-12
• Public Version Status: Update
• Public Device Record Key: 78d99ac7-739e-420b-b496-bbdec26a2000
• Distribution End Date: 2021-03-11

Device Description

DB LINGUAL BUTTON FLAT PAD 100/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: 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
ECN	CLAMP, WIRE, ORTHODONTIC	Dental	872.5410	1

GMDN Terms

Code	Name	Definition	Implantable	Status
63379	Orthodontic power arm/lock	An orthodontic device in the shape of a straight pin or hook designed to accept an elastic band, power chain, spring, or archwire (not included), which apply a force in addition to the main orthodontic archwire, for vertical alignment and/or horizontal positioning of the teeth; it also includes a base that functions as an orthodontic lock/stop. The device is crimped, soldered or screwed on an orthodontic attachment (e.g., bracket, archwire) or the surface of a tooth. This is a single-patient device intended to be used for the duration of treatment (single-use) before being discarded.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00190746151804	GS1

Customer Contacts

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