APC™ II SmartClip™ SL3 3004-2390

GUDID 00652221053893

SmartClip(TM) Self-Ligating Bracket APC(TM) II MBT(TM) LL4 -12T/2A OffsetBase .018 5/Pk

3M UNITEK CORPORATION

Orthodontic bracket, metal

• Primary Device ID: 00652221053893
• NIH Device Record Key: 06479d86-8838-4d9f-aaa6-55d1bb44fd8b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: APC™ II SmartClip™ SL3
• Version Model Number: 3004-2390
• Catalog Number: 3004-2390
• 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	00652221053893 [Primary]
GS1	80652221053899 [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 SmartClip™ SL3]

• 00652221149244: SmartClip(TM) Self-Ligating Bracket APC(TM) II Roth/Low Torque VPO U/L 5x5 .018 Kt
• 00652221148797: SmartClip(TM) Self-Ligating Bracket APC(TM) II Ricketts/High Torque VPO U/L 5x5 3,4,5Hk .022 Kt
• 00652221148780: SmartClip(TM) Self-Ligating Bracket APC(TM) II Ricketts/High Torque VPO U/L 5x5 3Hk .022 Kt
• 00652221148773: SmartClip(TM) Self-Ligating Bracket APC(TM) II Ricketts/High Torque VPO U/L 5x5 .022 Kt
• 00652221148766: SmartClip(TM) Self-Ligating Bracket APC(TM) II Ricketts/High Torque VPO U/L 5x5 3,4,5Hk .018 Kt
• 00652221148759: SmartClip(TM) Self-Ligating Bracket APC(TM) II Ricketts/High Torque VPO U/L 5x5 3Hk .018 Kt
• 00652221148742: SmartClip(TM) Self-Ligating Bracket APC(TM) II Ricketts/High Torque VPO U/L 5x5 .018 Kt
• 00652221148728: SmartClip(TM) Self-Ligating Bracket APC(TM) II Roth/Low Torque VPO U/L 5x5 3Hk .022 Kt
• 00652221148711: SmartClip(TM) Self-Ligating Bracket APC(TM) II Roth/Low Torque VPO U/L 5x5 .022 Kt
• 00652221148704: SmartClip(TM) Self-Ligating Bracket APC(TM) II Roth/Low Torque VPO U/L 5x5 3,4,5Hk .018 Kt
• 00652221148698: SmartClip(TM) Self-Ligating Bracket APC(TM) II Roth/Low Torque VPO U/L 5x5 3Hk .018 Kt
• 00652221148513: SmartClip(TM) Self-Ligating Bracket APC(TM) II Low Torque VPO UL4,5 -9T/0A Hk .018 5/Pk
• 00652221147721: SmartClip(TM) Self-Ligating Bracket APC(TM) II Medium Torque VPO LR3 -3T/3A Hk .022 5/Pk
• 00652221147714: SmartClip(TM) Self-Ligating Bracket APC(TM) II Medium Torque VPO LL3 -3T/3A Hk .022 5/Pk
• 00652221147707: SmartClip(TM) Self-Ligating Bracket APC(TM) II Medium Torque VPO LR3 -3T/3A .022 5/Pk
• 00652221147691: SmartClip(TM) Self-Ligating Bracket APC(TM) II Medium Torque VPO LL3 -3T/3A .022 5/Pk
• 00652221147684: SmartClip(TM) Self-Ligating Bracket APC(TM) II Ricketts/High Torque VPO LR3 7T/3A Hk .022 5/Pk
• 00652221147677: SmartClip(TM) Self-Ligating Bracket APC(TM) II Ricketts/High Torque VPO LL3 7T/3A Hk .022 5/Pk
• 00652221147660: SmartClip(TM) Self-Ligating Bracket APC(TM) II Ricketts/High Torque VPO LR3 7T/3A .022 5/Pk
• 00652221147653: SmartClip(TM) Self-Ligating Bracket APC(TM) II Ricketts/High Torque VPO LL3 7T/3A .022 5/Pk
• 00652221147639: SmartClip(TM) Self-Ligating Bracket APC(TM) II High Torque VPO UR4,5 -4T/0A Hk .022 5/Pk
• 00652221147622: SmartClip(TM) Self-Ligating Bracket APC(TM) II High Torque VPO UL4,5 -4T/0A Os Hk .022 5/Pk
• 00652221147615: SmartClip(TM) Self-Ligating Bracket APC(TM) II High Torque VPO UL4,5 -4T/0A Hk .022 5/Pk
• 00652221147592: SmartClip(TM) Self-Ligating Bracket APC(TM) II Low Torque VPO U4,5 -4T/0A .022 5/Pk
• 00652221147578: SmartClip(TM) Self-Ligating Bracket APC(TM) II Low Torque VPO UR4,5 -9T/0A Hk .022 5/Pk
• 00652221147554: SmartClip(TM) Self-Ligating Bracket APC(TM) II Low Torque VPO UL4,5 -9T/0A Hk .022 5/Pk
• 00652221147547: SmartClip(TM) Self-Ligating Bracket APC(TM) II Low Torque VPO U4,5 -9T/0A Os .022 5/Pk
• 00652221147523: SmartClip(TM) Self-Ligating Bracket APC(TM) II Medium Torque VPO UR3 3T/8A Hk .022 5/Pk
• 00652221147516: SmartClip(TM) Self-Ligating Bracket APC(TM) II Medium Torque VPO UL3 3T/8A Hk .022 5/Pk
• 00652221147448: SmartClip(TM) Self-Ligating Bracket APC(TM) II Ricketts/High Torque VPO UR3 6T/8A Hk .022 5/Pk
• 00652221147431: SmartClip(TM) Self-Ligating Bracket APC(TM) II Ricketts/High Torque VPO UL3 6T/8A Hk .022 5/Pk
• 00652221147400: SmartClip(TM) Self-Ligating Bracket APC(TM) II Roth/Low Torque VPO UR2 5T/8A .022 5/Pk
• 00652221147394: SmartClip(TM) Self-Ligating Bracket APC(TM) II Roth/Low Torque VPO UL2 5T/8A .022 5/Pk
• 00652221147387: SmartClip(TM) Self-Ligating Bracket APC(TM) II Ricketts/High Torque VPO UR2 15T/9A .022 5/Pk
• 00652221147370: SmartClip(TM) Self-Ligating Bracket APC(TM) II Ricketts/High Torque VPO UR2 15T/9A .018 5/Pk
• 00652221147363: SmartClip(TM) Self-Ligating Bracket APC(TM) II Ricketts/High Torque VPO UL2 15T/9A .022 5/Pk
• 00652221147356: SmartClip(TM) Self-Ligating Bracket APC(TM) II Roth/Low Torque VPO UR1 12T/3A .022 5/Pk
• 00652221147349: SmartClip(TM) Self-Ligating Bracket APC(TM) II Roth/Low Torque VPO UL1 12T/3A .022 5/Pk
• 00652221147332: SmartClip(TM) Self-Ligating Bracket APC(TM) II Ricketts/High Torque VPO UR1 22T/5A .022 5/Pk
• 00652221147325: SmartClip(TM) Self-Ligating Bracket APC(TM) II Ricketts/High Torque VPO UL1 22T/5A .022 5/Pk
• 00652221147318: SmartClip(TM) Self-Ligating Bracket APC(TM) II MBT(TM)/High Torque VPO UR1 22T/4A .022 5/Pk
• 00652221147301: SmartClip(TM) Self-Ligating Bracket APC(TM) II MBT(TM)/High Torque VPO UL1 22T/4A .022 5/Pk
• 00652221147295: SmartClip(TM) Self-Ligating Bracket APC(TM) II Medium Torque VPO LR3 -3T/3A Hk .018 5/Pk
• 00652221147288: SmartClip(TM) Self-Ligating Bracket APC(TM) II Medium Torque VPO LL3 -3T/3A Hk .018 5/Pk
• 00652221147257: SmartClip(TM) Self-Ligating Bracket APC(TM) II Ricketts/High Torque VPO LR3 7T/3A Hk .018 5/Pk
• 00652221147240: SmartClip(TM) Self-Ligating Bracket APC(TM) II Ricketts/High Torque VPO LL3 7T/3A Hk .018 5/Pk
• 00652221147219: SmartClip(TM) Self-Ligating Bracket APC(TM) II High Torque VPO UR4,5 -4T/0A Os Hk .018 5/Pk
• 00652221147202: SmartClip(TM) Self-Ligating Bracket APC(TM) II High Torque VPO UR4,5 -4T/0A Hk .018 5/Pk
• 00652221147196: SmartClip(TM) Self-Ligating Bracket APC(TM) II High Torque VPO UL4,5 -4T/0A Os Hk .018 5/Pk
• 00652221147189: SmartClip(TM) Self-Ligating Bracket APC(TM) II High Torque VPO UL4,5 -4T/0A Hk .018 5/Pk