APC™ PLUS Level Anchorage™ 5017-763

GUDID 00652221090829

Victory Series(TM) Bracket APC(TM) PLUS Level Anchorage Single UL3 0T/6A .018 5/Pk

3M UNITEK CORPORATION

Orthodontic bracket, metal

• Primary Device ID: 00652221090829
• NIH Device Record Key: e50ba389-e5b3-4d95-a773-e54ced53c5a3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: APC™ PLUS Level Anchorage™
• Version Model Number: 5017-763
• Catalog Number: 5017-763
• 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	00652221090829 [Primary]
GS1	80652221090825 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K020394

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™ PLUS Level Anchorage™]

• 00652221091727: Victory Series(TM) Bracket APC(TM) PLUS Level Anchorage Single LR5 -11T/-6A .022 5/Pk
• 00652221091703: Victory Series(TM) Bracket APC(TM) PLUS Level Anchorage Single LR4 -11T/-4A .022 5/Pk
• 00652221091697: Victory Series(TM) Bracket APC(TM) PLUS Level Anchorage Single LL4 -11T/-4A .022 5/Pk
• 00652221091680: Victory Series(TM) Bracket APC(TM) PLUS Level Anchorage Single UR3 0T/6A .022 5/Pk
• 00652221091673: Victory Series(TM) Bracket APC(TM) PLUS Level Anchorage Single UL3 0T/6A .022 5/Pk
• 00652221090874: Victory Series(TM) Bracket APC(TM) PLUS Level Anchorage Single LR5 -11T/-6A .018 5/Pk
• 00652221090867: Victory Series(TM) Bracket APC(TM) PLUS Level Anchorage Single LL5 -11T/-6A .018 5/Pk
• 00652221090850: Victory Series(TM) Bracket APC(TM) PLUS Level Anchorage Single LR4 -11T/-4A .018 5/Pk
• 00652221090843: Victory Series(TM) Bracket APC(TM) PLUS Level Anchorage Single LL4 -11T/-4A .018 5/Pk
• 00652221090836: Victory Series(TM) Bracket APC(TM) PLUS Level Anchorage Single UR3 0T/6A .018 5/Pk
• 00652221090829: Victory Series(TM) Bracket APC(TM) PLUS Level Anchorage Single UL3 0T/6A .018 5/Pk
• 00652221090812: Victory Series(TM) Bracket APC(TM) PLUS Level Anchorage Single LR3 0T/6A .018 5/Pk
• 00652221090805: Victory Series(TM) Bracket APC(TM) PLUS Level Anchorage Single LL3 0T/6A .018 5/Pk