Transbond™ XT 712-035

GUDID 00652221108951

Transbond(TM) XT 2-Syringe Kt

3M UNITEK CORPORATION

Orthodontic bracket adhesive

• Primary Device ID: 00652221108951
• NIH Device Record Key: 5ee5a863-f162-4484-8576-1f7ef6eb68cd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Transbond™ XT
• Version Model Number: 712-035
• Catalog Number: 712-035
• 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	00652221108951 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K880393

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

On-Brand Devices [Transbond™ XT]

• 00652221109071: Transbond(TM) XT Syringe 2/Pk
• 00652221108975: Transbond(TM) XT Syringe 4/Pk
• 00652221108951: Transbond(TM) XT 2-Syringe Kt
• 00652221108944: Transbond(TM) XT Primer 6 ml Bottle Ea
• 00652221108913: Transbond(TM) XT Adhesive Capsule 25/Bx
• 00652221108906: Transbond(TM) XT Capsule Kt