3M™ Unitek™ Clarity™ MBT™ 003-357

GUDID 00652221287366

Clarity Ultra SL Bkt MBT L Lt 1Bicuspid -12T/2A DHk 022

3M UNITEK CORPORATION

Orthodontic bracket, ceramic

• Primary Device ID: 00652221287366
• NIH Device Record Key: a6f335f7-6eed-43c7-8c8f-f448c470ce97
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 3M™ Unitek™ Clarity™ MBT™
• Version Model Number: 003-357
• Catalog Number: 003-357
• Company DUNS: 008256356
• Company Name: 3M UNITEK CORPORATION
• Device Count: 5
• DM Exempt: false
• Pre-market Exempt: false
• 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: true
• Serial Number: false
• Manufacturing Date: false
• 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(800)423-4588
• Email: 3Mhealthcarecompliance@mmm.com
• Phone: +1(800)423-4588
• Email: 3Mhealthcarecompliance@mmm.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00652221287366 [Primary]
GS1	80652221287362 [Unit of Use]

FDA Product Code

• NJM: Bracket, ceramic, 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: 2019-02-12
• Device Publish Date: 2018-10-23

On-Brand Devices [3M™ Unitek™ Clarity™ MBT™]

• 00652221287410: Clarity Ultra SL Bkt MBT L Rt 2Bicuspid -17T/2A DHk 022
• 00652221287403: Clarity Ultra SL Bkt MBT L Lt 2Bicuspid -17T/2A DHk 022
• 00652221287373: Clarity Ultra SL Bkt MBT L Rt 1Bicuspid -12T/2A DHk 022
• 00652221287366: Clarity Ultra SL Bkt MBT L Lt 1Bicuspid -12T/2A DHk 022
• 00652221287335: Clarity Ultra SL Bkt MBT L Rt Cuspid 0T/3A DHk 022
• 00652221287328: Clarity Ultra SL Bkt MBT L Lt Cuspid 0T/3A DHk 022
• 00652221287311: Clarity Ultra SL Bkt MBT L Lt/Rt Anterior -6T/0A 022
• 00652221287304: Clarity Ultra SL Bkt MBT U Rt Bicuspid -7T/0A DHk 022
• 00652221287298: Clarity Ultra SL Bkt MBT U Lt Bicuspid -7T/0A DHk 022
• 00652221287274: Clarity Ultra SL Bkt MBT U Rt Cuspid 0T/8A DHk 022
• 00652221287267: Clarity Ultra SL Bkt MBT U Lt Cuspid 0T/8A DHk 022
• 00652221287250: Clarity Ultra SL Bkt MBT U Rt Lateral 10T/8A 022
• 00652221287243: Clarity Ultra SL Bkt MBT U Lt Lateral 10T/8A 022
• 00652221287236: Clarity Ultra SL Bkt MBT U Rt Central 17T/4A 022