SureSmile®

Basic Information

• Brand Name: SureSmile®
• Primary DI: D746ORX000051
• Version / Model: ORX00005
• Company Name: DENTSPLY SIRONA ORTHODONTICS INC.
• Labeler DUNS: 116903307
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-12-16
• Public Version: 3
• Public Version Date: 2023-10-30
• Public Version Status: Update
• Public Device Record Key: 4cfd921b-2724-446b-a50d-59183eaa0253

Device Description

SureSmile® Aligner Patient Kit (Global)

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• 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
NYC	Dental Prophylaxis Kit	Dental	872.4565	1

GMDN Terms

Code	Name	Definition	Implantable	Status
63675	Orthodontic retainer support kit	A collection of devices intended to be used to facilitate use of an orthodontic teeth retainer (positioner), including placement, removal and cleaning. It typically consists of an orthodontic appliance remover, an orthodontic retainer seater, and an orthodontic appliance cleanser. The aligner, appliance or retainer is not included. This is a single-patient, reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	D746ORX000051	HIBCC

Customer Contacts

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