APC™ II Level Anchorage™ 3017-765

GUDID 00652221059673

Victory Series(TM) Bracket APC(TM) II Level Anchorage Single LL4 -11T/-4A .018 5/Pk

3M UNITEK CORPORATION

Orthodontic bracket, metal

• Primary Device ID: 00652221059673
• NIH Device Record Key: f54a9cbe-de9a-4ada-b7af-5904647d0319
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: APC™ II Level Anchorage™
• Version Model Number: 3017-765
• Catalog Number: 3017-765
• 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: 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	00652221059673 [Primary]
GS1	80652221059679 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K911271

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 [APC™ II Level Anchorage™]

• 00652221060556: Victory Series(TM) Bracket APC(TM) II Level Anchorage Single LR5 -11T/-6A .022 5/Pk
• 00652221060532: Victory Series(TM) Bracket APC(TM) II Level Anchorage Single LR4 -11T/-4A .022 5/Pk
• 00652221059703: Victory Series(TM) Bracket APC(TM) II Level Anchorage Single LR5 -11T/-6A .018 5/Pk
• 00652221059697: Victory Series(TM) Bracket APC(TM) II Level Anchorage Single LL5 -11T/-6A .018 5/Pk
• 00652221059680: Victory Series(TM) Bracket APC(TM) II Level Anchorage Single LR4 -11T/-4A .018 5/Pk
• 00652221059673: Victory Series(TM) Bracket APC(TM) II Level Anchorage Single LL4 -11T/-4A .018 5/Pk
• 00652221059666: Victory Series(TM) Bracket APC(TM) II Level Anchorage Single UR3 0T/6A .018 5/Pk
• 00652221059659: Victory Series(TM) Bracket APC(TM) II Level Anchorage Single UL3 0T/6A .018 5/Pk
• 00652221059642: Victory Series(TM) Bracket APC(TM) II Level Anchorage Single LR3 0T/6A .018 5/Pk
• 00652221059635: Victory Series(TM) Bracket APC(TM) II Level Anchorage Single LL3 0T/6A .018 5/Pk