APC™ II Victory Series™ Active 3025-311

GUDID 00652221220158

Victory Series(TM) Active SL Bracket APC(TM) II Roth UR4,5 -7T/0A Hk .022 5/Pk

3M UNITEK CORPORATION

Orthodontic bracket, metal Orthodontic bracket, metal

• Primary Device ID: 00652221220158
• NIH Device Record Key: f2ebfc2e-9b2c-4554-adbb-5c7986e1f619
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: APC™ II Victory Series™ Active
• Version Model Number: 3025-311
• Catalog Number: 3025-311
• 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	00652221220158 [Primary]
GS1	80652221220154 [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 Victory Series™ Active]

• 00652221223913: Victory Series(TM) Active SL Bracket APC(TM) II Roth U/L 5x5 3,4,5Hk .022 Kt
• 00652221220288: Victory Series(TM) Active SL Bracket APC(TM) II Roth LR5 -22T/0A Hk .022 5/Pk
• 00652221220271: Victory Series(TM) Active SL Bracket APC(TM) II Roth LL5 -22T/0A Hk .022 5/Pk
• 00652221220257: Victory Series(TM) Active Self-Ligating Bracket APC(TM) II Roth LL5 -22T/0A .022 5/Pk
• 00652221220240: Victory Series(TM) Active SL Bracket APC(TM) II Roth LR4 -17T/0A Hk .022 5/Pk
• 00652221220233: Victory Series(TM) Active SL Bracket APC(TM) II Roth LL4 -17T/0A Hk .022 5/Pk
• 00652221220219: Victory Series(TM) Active Self-Ligating Bracket APC(TM) II Roth LL4 -17T/0A .022 5/Pk
• 00652221220202: Victory Series(TM) Active SL Bracket APC(TM) II Roth LR3 -11T/7A Hk .022 5/Pk
• 00652221220196: Victory Series(TM) Active SL Bracket APC(TM) II Roth LL3 -11T/7A Hk .022 5/Pk
• 00652221220189: Victory Series(TM) Active Self-Ligating Bracket APC(TM) II Roth LR3 -11T/7A .022 5/Pk
• 00652221220172: Victory Series(TM) Active Self-Ligating Bracket APC(TM) II Roth LL3 -11T/7A .022 5/Pk
• 00652221220165: Victory Series(TM) Active Self-Ligating Bracket APC(TM) II Roth L1,2 -1T/0A .022 5/Pk
• 00652221220158: Victory Series(TM) Active SL Bracket APC(TM) II Roth UR4,5 -7T/0A Hk .022 5/Pk
• 00652221220141: Victory Series(TM) Active SL Bracket APC(TM) II Roth UL4,5 -7T/0A Hk .022 5/Pk
• 00652221220134: Victory Series(TM) Active Self-Ligating Bracket APC(TM) II Roth U4,5 -7T/0A .022 5/Pk
• 00652221220127: Victory Series(TM) Active SL Bracket APC(TM) II Roth UR3 -2T/10A Hk .022 5/Pk
• 00652221220110: Victory Series(TM) Active SL Bracket APC(TM) II Roth UL3 -2T/10A Hk .022 5/Pk
• 00652221220103: Victory Series(TM) Active Self-Ligating Bracket APC(TM) II Roth UR3 -2T/10A .022 5/Pk
• 00652221220097: Victory Series(TM) Active Self-Ligating Bracket APC(TM) II Roth UL3 -2T/10A .022 5/Pk
• 00652221220080: Victory Series(TM) Active SL Bracket APC(TM) II Roth UR2 8T/9A .022 5/Pk
• 00652221220073: Victory Series(TM) Active SL Bracket APC(TM) II Roth UL2 8T/9A .022 5/Pk
• 00652221220066: Victory Series(TM) Active SL Bracket APC(TM) II Roth UR1 12T/5A .022 5/Pk
• 00652221220059: Victory Series(TM) Active SL Bracket APC(TM) II Roth UL1 12T/5A .022 5/Pk