Motto ASSY-500019

GUDID 00856379007306

Motto Retainer

ORAMETRIX, INC.

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• Primary Device ID: 00856379007306
• NIH Device Record Key: e6c6514b-7e92-4779-b1ba-1eb8a774f9da
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Motto
• Version Model Number: ASSY-500019
• Catalog Number: ASSY-500019
• Company DUNS: 053101262
• Company Name: ORAMETRIX, 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: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• 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: SureSmile-Customer-Care@dentsplysirona.com
• Phone: +1(844)848-0137
• Email: SureSmile-Customer-Care@dentsplysirona.com
• Phone: +1(844)848-0137
• Email: SureSmile-Customer-Care@dentsplysirona.com
• Phone: +1(844)848-0137
• Email: SureSmile-Customer-Care@dentsplysirona.com
• Phone: +1(844)848-0137
• Email: SureSmile-Customer-Care@dentsplysirona.com
• Phone: +1(844)848-0137
• Email: SureSmile-Customer-Care@dentsplysirona.com
• Phone: +1(844)848-0137
• Email: SureSmile-Customer-Care@dentsplysirona.com
• Phone: +1(844)848-0137
• Email: SureSmile-Customer-Care@dentsplysirona.com
• Phone: +1(844)848-0137
• Email: SureSmile-Customer-Care@dentsplysirona.com
• Phone: +1(844)848-0137
• Email: SureSmile-Customer-Care@dentsplysirona.com
• Phone: +1(844)848-0137
• Email: SureSmile-Customer-Care@dentsplysirona.com
• Phone: +1(844)848-0137
• Email: SureSmile-Customer-Care@dentsplysirona.com
• Phone: +1(844)848-0137
• Email: SureSmile-Customer-Care@dentsplysirona.com
• Phone: +1(844)848-0137
• Email: SureSmile-Customer-Care@dentsplysirona.com
• Phone: +1(844)848-0137
• Email: SureSmile-Customer-Care@dentsplysirona.com
• Phone: +1(844)848-0137
• Email: SureSmile-Customer-Care@dentsplysirona.com
• Phone: +1(844)848-0137
• Email: SureSmile-Customer-Care@dentsplysirona.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00856379007306 [Primary]

FDA Product Code

• KMY: POSITIONER, TOOTH, PREFORMED

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: 2023-03-16
• Device Publish Date: 2023-03-08

On-Brand Devices [Motto]

• 00856379007306: Motto Retainer
• 00856379007290: Motto Attachment Template
• 00856379007283: Motto Aligner