Ortho Dots

Basic Information

• Brand Name: Ortho Dots
• Primary DI: E53555K71000001
• Version / Model: 55-K710-0000
• Catalog Number: 55-K710-0000
• Company Name: Gc Orthodontics America Inc.
• Labeler DUNS: 063167128
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 4
• Record Status: Published
• Publish Date: 2021-08-26
• Public Version: 2
• Public Version Date: 2022-01-27
• Public Version Status: Update
• Public Device Record Key: 11902a3f-e0bf-41aa-ab88-a564b8c6367a
• Distribution End Date: 2022-01-26

Device Description

Ortho Dots ® CLEAR Patient Packs4-count

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: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
EGD	WAX, DENTAL, INTRAORAL	Dental	872.6890	1

GMDN Terms

Code	Name	Definition	Implantable	Status
45251	Orthodontic appliance relief material	A device used to cover the offending sharp edges of an orthodontic appliance being worn by the user in order to provide relief from the discomforts that this can cause. It can be presented as a sheet, strip, or rod and is typically made of a mouldable wax or silicone material that is easy to manipulate with the fingers in order to cover the offending protrusions of the orthodontic appliance that are causing irritations in the patient's mouth. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	E53555K71000000	HIBCC
Primary	E53555K71000001	HIBCC

Customer Contacts

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