APC™ PLUS SmartClip™ SL3 5004-7011

GUDID 00652221146373

SmartClip(TM) APC(TM) PLUS Bondable MBT(TM) UL6 -14T/10Off .022 4/Pk

3M UNITEK CORPORATION

Orthodontic bracket, metal Orthodontic bracket, metal Orthodontic bracket, metal Orthodontic bracket, metal Orthodontic bracket, metal Orthodontic bracket, metal Orthodontic bracket, metal Orthodontic bracket, metal Orthodontic bracket, metal Orthodontic bracket, metal Orthodontic bracket, metal Orthodontic bracket, metal

• Primary Device ID: 00652221146373
• NIH Device Record Key: 53a0c77b-eff1-4a0b-aed7-09cf4bed2fa5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: APC™ PLUS SmartClip™ SL3
• Version Model Number: 5004-7011
• Catalog Number: 5004-7011
• Company DUNS: 008256356
• Company Name: 3M UNITEK CORPORATION
• Device Count: 4
• 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
• Phone: +1(800)423-4588
• Email: 3Mhealthcarecompliance@mmm.com
• Phone: +1(800)423-4588
• Email: 3Mhealthcarecompliance@mmm.com
• Phone: +1(800)423-4588
• Email: 3Mhealthcarecompliance@mmm.com
• Phone: +1(800)423-4588
• Email: 3Mhealthcarecompliance@mmm.com
• Phone: +1(800)423-4588
• Email: 3Mhealthcarecompliance@mmm.com
• Phone: +1(800)423-4588
• Email: 3Mhealthcarecompliance@mmm.com
• Phone: +1(800)423-4588
• Email: 3Mhealthcarecompliance@mmm.com
• Phone: +1(800)423-4588
• Email: 3Mhealthcarecompliance@mmm.com
• 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	00652221146373 [Primary]
GS1	80652221146379 [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 SmartClip™ SL3]

• 00652221149336: SmartClip(TM) Self-Ligating Bracket APC(TM) PLUS Ricketts/High Torque VPO U/L 5x5 .018 Kt
• 00652221149237: SmartClip(TM) Self-Ligating Bracket APC(TM) PLUS Roth/Low Torque VPO U/L 5x5 3,4,5Hk .018 Kt
• 00652221148902: SmartClip(TM) Self-Ligating Bracket APC(TM) PLUS Ricketts/High Torque VPO U/L 5x5 3,4,5Hk .022 K
• 00652221148896: SmartClip(TM) Self-Ligating Bracket APC(TM) PLUS Ricketts/High Torque VPO U/L 5x5 3Hk .022 Kt
• 00652221148889: SmartClip(TM) Self-Ligating Bracket APC(TM) PLUS Ricketts/High Torque VPO U/L 5x5 .022 Kt
• 00652221148872: SmartClip(TM) Self-Ligating Bracket APC(TM) PLUS Ricketts/High Torque VPO U/L 5x5 3,4,5Hk .018 K
• 00652221148841: SmartClip(TM) Self-Ligating Bracket APC(TM) PLUS Roth/Low Torque VPO U/L 5x5 3,4,5Hk .022 Kt
• 00652221148834: SmartClip(TM) Self-Ligating Bracket APC(TM) PLUS Roth/Low Torque VPO U/L 5x5 3Hk .022 Kt
• 00652221148827: SmartClip(TM) Self-Ligating Bracket APC(TM) PLUS Roth/Low Torque VPO U/L 5x5 .022 Kt
• 00652221148810: SmartClip(TM) Self-Ligating Bracket APC(TM) PLUS Roth/Low Torque VPO U/L 5x5 3Hk .018 Kt
• 00652221148803: SmartClip(TM) Self-Ligating Bracket APC(TM) PLUS Roth/Low Torque VPO U/L 5x5 .018 Kt
• 00652221148537: SmartClip(TM) Self-Ligating Bracket APC(TM) PLUS Ricketts/High Torque VPO UR3 6T/8A Hk .022 5/Pk
• 00652221148520: SmartClip(TM) Self-Ligating Bracket APC(TM) PLUS Roth/Low Torque VPO UR1 12T/3A .022 5/Pk
• 00652221148506: SmartClip(TM) Self-Ligating Bracket APC(TM) PLUS Ricketts/High Torque VPO UR2 15T/9A .022 5/Pk
• 00652221148490: SmartClip(TM) Self-Ligating Bracket APC(TM) PLUS Medium Torque VPO LR3 -3T/3A Hk .022 5/Pk
• 00652221148483: SmartClip(TM) Self-Ligating Bracket APC(TM) PLUS Medium Torque VPO LL3 -3T/3A Hk .022 5/Pk
• 00652221148476: SmartClip(TM) Self-Ligating Bracket APC(TM) PLUS Medium Torque VPO LR3 -3T/3A .022 5/Pk
• 00652221148469: SmartClip(TM) Self-Ligating Bracket APC(TM) PLUS Medium Torque VPO LL3 -3T/3A .022 5/Pk
• 00652221148452: SmartClip(TM) Self-Ligating Bracket APC(TM) PLUS Ricketts/High Torque VPO LR3 7T/3A Hk .018 5/Pk
• 00652221148445: SmartClip(TM) Self-Ligating Bracket APC(TM) PLUS Ricketts/High Torque VPO LR3 7T/3A Hk .022 5/Pk
• 00652221148438: SmartClip(TM) Self-Ligating Bracket APC(TM) PLUS Ricketts/High Torque VPO LL3 7T/3A Hk .022 5/Pk
• 00652221148421: SmartClip(TM) Self-Ligating Bracket APC(TM) PLUS Ricketts/High Torque VPO LR3 7T/3A .022 5/Pk
• 00652221148414: SmartClip(TM) Self-Ligating Bracket APC(TM) PLUS Ricketts/High Torque VPO LL3 7T/3A .022 5/Pk
• 00652221148407: SmartClip(TM) Self-Ligating Bracket APC(TM) PLUS High Torque VPO UR4,5 -4T/0A Os Hk .022 5/Pk
• 00652221148391: SmartClip(TM) Self-Ligating Bracket APC(TM) PLUS High Torque VPO UR4,5 -4T/0A Hk .022 5/Pk
• 00652221148384: SmartClip(TM) Self-Ligating Bracket APC(TM) PLUS High Torque VPO UL4,5 -4T/0A Os Hk .022 5/Pk
• 00652221148377: SmartClip(TM) Self-Ligating Bracket APC(TM) PLUS High Torque VPO UL4,5 -4T/0A Hk .022 5/Pk
• 00652221148360: SmartClip(TM) Self-Ligating Bracket APC(TM) PLUS Low Torque VPO U4,5 -4T/0A Os .022 5/Pk
• 00652221148353: SmartClip(TM) Self-Ligating Bracket APC(TM) PLUS Low Torque VPO U4,5 -4T/0A .022 5/Pk
• 00652221148339: SmartClip(TM) Self-Ligating Bracket APC(TM) PLUS Low Torque VPO UR4,5 -9T/0A Hk .022 5/Pk
• 00652221148315: SmartClip(TM) Self-Ligating Bracket APC(TM) PLUS Low Torque VPO UL4,5 -9T/0A Hk .022 5/Pk
• 00652221148308: SmartClip(TM) Self-Ligating Bracket APC(TM) PLUS Low Torque VPO U4,5 -9T/0A Os .022 5/Pk
• 00652221148285: SmartClip(TM) Self-Ligating Bracket APC(TM) PLUS Medium Torque VPO UR3 3T/8A Hk .022 5/Pk
• 00652221148278: SmartClip(TM) Self-Ligating Bracket APC(TM) PLUS Medium Torque VPO UL3 3T/8A Hk .022 5/Pk
• 00652221148247: SmartClip(TM) Self-Ligating Bracket APC(TM) PLUS Ricketts/High Torque VPO UL3 6T/8A Hk .022 5/Pk
• 00652221148230: SmartClip(TM) Self-Ligating Bracket APC(TM) PLUS Ricketts/High Torque VPO UR3 6T/8A .022 5/Pk
• 00652221148223: SmartClip(TM) Self-Ligating Bracket APC(TM) PLUS Ricketts/High Torque VPO UL3 6T/8A .022 5/Pk
• 00652221148216: SmartClip(TM) Self-Ligating Bracket APC(TM) PLUS Roth/Low Torque VPO UR2 5T/8A .022 5/Pk
• 00652221148209: SmartClip(TM) Self-Ligating Bracket APC(TM) PLUS Roth/Low Torque VPO UL2 5T/8A .022 5/Pk
• 00652221148193: SmartClip(TM) Self-Ligating Bracket APC(TM) PLUS Ricketts/High Torque VPO UL2 15T/9A .022 5/Pk
• 00652221148186: SmartClip(TM) Self-Ligating Bracket APC(TM) PLUS Roth/Low Torque VPO UL1 12T/3A .022 5/Pk
• 00652221148179: SmartClip(TM) Self-Ligating Bracket APC(TM) PLUS Ricketts/High Torque VPO UR1 22T/5A .022 5/Pk
• 00652221148162: SmartClip(TM) Self-Ligating Bracket APC(TM) PLUS Ricketts/High Torque VPO UL1 22T/5A .022 5/Pk
• 00652221148155: SmartClip(TM) Self-Ligating Bracket APC(TM) PLUS MBT(TM)/High Torque VPO UR1 22T/4A .022 5/Pk
• 00652221148148: SmartClip(TM) Self-Ligating Bracket APC(TM) PLUS MBT(TM)/High Torque VPO UL1 22T/4A .022 5/Pk
• 00652221148131: SmartClip(TM) Self-Ligating Bracket APC(TM) PLUS Medium Torque VPO LR3 -3T/3A Hk .018 5/Pk
• 00652221148124: SmartClip(TM) Self-Ligating Bracket APC(TM) PLUS Medium Torque VPO LL3 -3T/3A Hk .018 5/Pk
• 00652221148094: SmartClip(TM) Self-Ligating Bracket APC(TM) PLUS Ricketts/High Torque VPO LL3 7T/3A Hk .018 5/Pk
• 00652221148087: SmartClip(TM) Self-Ligating Bracket APC(TM) PLUS Ricketts/High Torque VPO LR3 7T/3A .018 5/Pk
• 00652221148070: SmartClip(TM) Self-Ligating Bracket APC(TM) PLUS Ricketts/High Torque VPO LL3 7T/3A .018 5/Pk