Transbond™ Supreme LV 712-046

GUDID 00652221134400

Transbond(TM) Supreme LV Low Viscosity Light Cure Adhesive Kt

3M UNITEK CORPORATION

Orthodontic bracket adhesive

• Primary Device ID: 00652221134400
• NIH Device Record Key: b588fe00-590f-47e8-ba64-c24c121152d1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Transbond™ Supreme LV
• Version Model Number: 712-046
• Catalog Number: 712-046
• Company DUNS: 008256356
• Company Name: 3M UNITEK CORPORATION
• Device Count: 1
• 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: 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(800)423-4588
• Email: 3Mhealthcarecompliance@mmm.com
• Phone: +1(800)423-4588
• Email: 3Mhealthcarecompliance@mmm.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00652221134400 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K073697

FDA Product Code

• DYH: ADHESIVE, BRACKET AND TOOTH CONDITIONER, RESIN

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-24

Devices Manufactured by 3M UNITEK CORPORATION

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• 80652221161907 - 3M™ Unitek™: 2023-09-18 3M™ Unitek™ TAD Contra Angle Adapter O-Ring, 504-319, 5/Pk
• 00652221303356 - 3M™ Unitek™: 2023-06-30 3M™ Unitek™ Elastics, 404-116, Light 2 oz, 1/8 in, Purple (Carlos), 100/Pk, 30 Pk/Ct
• 00652221303363 - 3M™ Unitek™: 2023-06-30 3M™ Unitek™ Elastics, 404-126, Light 2 oz, 3/16 in, Green (Pete), 100/Pk, 30 Pk/Ct
• 00652221303370 - 3M™ Unitek™: 2023-06-30 3M™ Unitek™ Elastics, 404-136, Light 2 oz, 1/4 in, Red (Gary), 100/Pk, 30 Pk/Ct
• 00652221303387 - 3M™ Unitek™: 2023-06-30 3M™ Unitek™ Elastics, 404-146, Light 2 oz, 5/16 in, Blue (Greg), 100/Pk, 30 Pk/Ct
• 00652221303394 - 3M™ Unitek™: 2023-06-30 3M™ Unitek™ Elastics, 404-156, Light 2 oz, 3/8 in, Orange (Tom), 100/Pk, 30 Pk/Ct
• 00652221303400 - 3M™ Unitek™: 2023-06-30 3M™ Unitek™ Elastics, 404-166, Light 2 oz, 5/8 in, Aqua (Andy), 100/Pk, 30 Pk/Ct