Ortho Shop

Basic Information

• Brand Name: Ortho Shop
• Primary DI: 00810152071625
• Version / Model: 8702-00
• Catalog Number: 8702-00
• Company Name: Orthoshop, LLC
• Labeler DUNS: 129808388
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2023-11-24
• Public Version: 1
• Public Version Date: 2023-12-04
• Public Version Status: New
• Public Device Record Key: 16e7005f-3a14-43e4-ae8a-d83bdfda1619

Device Description

Bondable Lingual Buttons Round

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• 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: 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
EJF	Bracket, Metal, Orthodontic	Dental	872.5410	1

GMDN Terms

Code	Name	Definition	Implantable	Status
63223	Orthodontic power arm	A dental 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 may include a base that functions as an orthodontic lock/stop. The device is typically crimped, soldered, screwed on, or inserted in the slot of an orthodontic attachment (e.g., bracket, band), or on the surface of a tooth for orthodontic traction. This is a single-patient device intended to be used for the duration of 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	10810152071622	GS1
Primary	00810152071625	GS1