APC™ PLUS SmartClip™ SL3 5004-248

GUDID 00652221085047

SmartClip(TM) Self-Ligating Bracket APC(TM) PLUS MBT(TM) LR5 -17T/2A .018 5/Pk

3M UNITEK CORPORATION

Orthodontic bracket, metal

• Primary Device ID: 00652221085047
• NIH Device Record Key: ee52b6f9-bfdb-45bc-a4bf-fe1bdc3dbb81
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: APC™ PLUS SmartClip™ SL3
• Version Model Number: 5004-248
• Catalog Number: 5004-248
• 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
• 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	00652221085047 [Primary]
GS1	80652221085043 [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