Unitek™ 712-050

GUDID 00652221109026

Unitek(TM) Multi-Cure Glass Ionomer Orthodontic Band Cement Kt

3M UNITEK CORPORATION

Glass ionomer dental cement Glass ionomer dental cement

• Primary Device ID: 00652221109026
• NIH Device Record Key: a43f7d60-51d2-45ed-93c2-e3d046a3d687
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Unitek™
• Version Model Number: 712-050
• Catalog Number: 712-050
• 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	00652221109026 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K950514

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 [Unitek™]

• 00652221109040: Unitek(TM) Multi-Cure Glass Ionomer Orthodontic Band Cement Liquid 25 g Bottle Ea
• 00652221109033: Unitek(TM) Multi-Cure Glass Ionomer Orthodontic Band Cement Powder 35 g Bottle Ea
• 00652221109026: Unitek(TM) Multi-Cure Glass Ionomer Orthodontic Band Cement Kt