SureSmile

Basic Information

• Brand Name: SureSmile
• Primary DI: D001V181001
• Version / Model: V18100
• Company Name: Dentsply International Inc.
• Labeler DUNS: 795572718
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-11-11
• Public Version: 1
• Public Version Date: 2022-11-21
• Public Version Status: New
• Public Device Record Key: 79f4f544-13e5-4fc5-90ca-9f2b3481e055

Device Characteristics

• Single Use: No
• 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: No
• 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
OYH	Orthodontic vibratory accessory	Dental	872.5470	2

GMDN Terms

Code	Name	Definition	Implantable	Status
62310	Orthodontic vibrator	An electronic device designed to be used in the home during treatment with orthodontic appliances (e.g., brackets, aligners) to provide small vibrations for gently accelerating the movement of anterior teeth, guided by the appliances, to help reduce treatment time and pain. It is in the form of a biteable plastic mouthpiece attached to a hands-free vibratory unit. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	D001V181001	HIBCC