SureSmile® ASSY-000471

GUDID 00856379007221

Arch wire 16x22 BETA TITANIUM

ORAMETRIX, INC.

Orthodontic archwire Orthodontic archwire Orthodontic archwire Orthodontic archwire Orthodontic archwire Orthodontic archwire Orthodontic archwire Orthodontic archwire Orthodontic archwire Orthodontic archwire Orthodontic archwire Orthodontic archwire Orthodontic archwire Orthodontic archwire Orthodontic archwire Orthodontic archwire Orthodontic archwire Orthodontic archwire Orthodontic archwire Orthodontic archwire Orthodontic archwire Orthodontic archwire Orthodontic archwire Orthodontic archwire

• Primary Device ID: 00856379007221
• NIH Device Record Key: df8fa743-bcac-4c91-9289-2523026b79fa
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SureSmile®
• Version Model Number: ASSY-000471
• Catalog Number: ASSY-000471
• 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: true
• 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	00856379007221 [Primary]

FDA Product Code

• DZC: Wire, Orthodontic

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2022-05-17
• Device Publish Date: 2021-05-28

On-Brand Devices [SureSmile®]

• 00856379007269: Retainer
• 90856379007118: Indirect Bonding (IDB) Tray
• 00856379007252: Arch wire 18x18 CUNITI-NITI
• 00856379007245: Arch wire 19x25 BETA TITANIUM
• 00856379007238: Arch wire 17x25 BETA TITANIUM
• 00856379007221: Arch wire 16x22 BETA TITANIUM
• 00856379007214: Arch wire 16x16 BETA TITANIUM
• 00856379007207: Arch wire 16round BETA TITANIUM
• 00856379007191: Arch wire 16x16 NITI
• 00856379007184: Arch wire 16x22 AZURLOY-ELGILOY
• 00856379007177: Arch wire 19x25 ELGILOY
• 00856379007160: Arch wire 17x25 ELGILOY
• 00856379007153: Arch wire 19x25 CUNITI-NITI
• 00856379007146: Arch wire 17x25 CUNITI-NITI
• 00856379007139: Arch wire 16x22 CUNITI-NITI
• 00856379007122: Arch wire 16round CUNITI-NITI