Unite™ 704-055

GUDID 00652221108289

Unite(TM) Primer 15 ml Bottle Ea

3M UNITEK CORPORATION

Orthodontic bracket adhesive

• Primary Device ID: 00652221108289
• NIH Device Record Key: 23814e93-893c-408f-879b-8506ca95f5d8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Unite™
• Version Model Number: 704-055
• Catalog Number: 704-055
• 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	00652221108289 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K014142

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 [Unite™]

• 00652221108838: Unite(TM) Bonding Adhesive 3-Syringe Kt
• 00652221108296: Unitek(TM) Etching Gel Blue Tint 9 ml Bottle Ea
• 00652221108289: Unite(TM) Primer 15 ml Bottle Ea
• 00652221108258: Unite(TM) Adhesive Syringes 3/Pk