SureSmile®

GUDID D746ORX000051

SureSmile® Aligner Patient Kit (Global)

DENTSPLY SIRONA ORTHODONTICS INC.

Orthodontic positioner support kit Orthodontic positioner support kit Orthodontic positioner support kit Orthodontic positioner support kit Orthodontic positioner support kit Orthodontic positioner support kit Orthodontic positioner support kit Orthodontic positioner support kit Orthodontic positioner support kit Orthodontic positioner support kit Orthodontic positioner support kit Orthodontic positioner support kit Orthodontic positioner support kit Orthodontic positioner support kit Orthodontic positioner support kit Orthodontic positioner support kit Orthodontic positioner support kit Orthodontic retainer support kit Orthodontic retainer support kit Orthodontic retainer support kit Orthodontic retainer support kit Orthodontic retainer support kit Orthodontic retainer support kit Orthodontic retainer support kit Orthodontic retainer support kit Orthodontic retainer support kit Orthodontic retainer support kit Orthodontic retainer support kit Orthodontic retainer support kit Orthodontic retainer support kit Orthodontic retainer support kit Orthodontic retainer support kit Orthodontic retainer support kit Orthodontic retainer support kit Orthodontic retainer support kit Orthodontic retainer support kit Orthodontic retainer support kit Orthodontic retainer support kit Orthodontic retainer support kit Orthodontic retainer support kit Orthodontic retainer support kit Orthodontic retainer support kit Orthodontic retainer support kit Orthodontic retainer support kit Orthodontic retainer support kit Orthodontic retainer support kit Orthodontic retainer support kit Orthodontic retainer support kit

• Primary Device ID: D746ORX000051
• NIH Device Record Key: 4cfd921b-2724-446b-a50d-59183eaa0253
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SureSmile®
• Version Model Number: ORX00005
• Company DUNS: 116903307
• Company Name: DENTSPLY SIRONA ORTHODONTICS INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(844)848-0137
• Email: essix.sales@dentsplysirona.com
• Phone: +1(844)848-0137
• Email: essix.sales@dentsplysirona.com
• Phone: +1(844)848-0137
• Email: essix.sales@dentsplysirona.com
• Phone: +1(844)848-0137
• Email: essix.sales@dentsplysirona.com
• Phone: +1(844)848-0137
• Email: essix.sales@dentsplysirona.com
• Phone: +1(844)848-0137
• Email: essix.sales@dentsplysirona.com
• Phone: +1(844)848-0137
• Email: essix.sales@dentsplysirona.com
• Phone: +1(844)848-0137
• Email: essix.sales@dentsplysirona.com
• Phone: +1(844)848-0137
• Email: essix.sales@dentsplysirona.com
• Phone: +1(844)848-0137
• Email: essix.sales@dentsplysirona.com
• Phone: +1(844)848-0137
• Email: essix.sales@dentsplysirona.com
• Phone: +1(844)848-0137
• Email: essix.sales@dentsplysirona.com
• Phone: +1(844)848-0137
• Email: essix.sales@dentsplysirona.com
• Phone: +1(844)848-0137
• Email: essix.sales@dentsplysirona.com
• Phone: +1(844)848-0137
• Email: essix.sales@dentsplysirona.com
• Phone: +1(844)848-0137
• Email: essix.sales@dentsplysirona.com
• Phone: +1(844)848-0137
• Email: essix.sales@dentsplysirona.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D746ORX000051 [Primary]

FDA Product Code

• NYC: Dental Prophylaxis Kit

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-12-24
• Device Publish Date: 2021-12-16

On-Brand Devices [SureSmile®]

• D746ORX000060: SureSmile Dr Starter Kit, EU
• D746ORX000010: SureSmile Dr Starter Kit
• D746ORX000051: SureSmile® Aligner Patient Kit (Global)