APC™ PLUS Clarity™ SL 5007-519

GUDID 00652221120434

Clarity(TM) SL Self-Ligating Bracket APC(TM) PLUS Roth UL2 8T/9A .018 5/Pk

3M UNITEK CORPORATION

Orthodontic bracket, ceramic Orthodontic bracket, ceramic

• Primary Device ID: 00652221120434
• NIH Device Record Key: c853c923-3248-4810-8e54-a42d9dc722c3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: APC™ PLUS Clarity™ SL
• Version Model Number: 5007-519
• Catalog Number: 5007-519
• 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	00652221120434 [Primary]
GS1	80652221120430 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K062305

FDA Product Code

• NJM: Bracket, ceramic, orthodontic

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 Clarity™ SL]

• 00652221151926: Clarity(TM) SL Self-Ligating Bracket APC(TM) PLUS High Torque VPO UL3 6T/8A Hk .022 5/Pk
• 00652221151834: Clarity(TM) SL Self-Ligating Bracket APC(TM) PLUS High Torque VPO U 3x3 3Hk .022 Kt
• 00652221151827: Clarity(TM) SL Self-Ligating Bracket APC(TM) PLUS High Torque VPO U 3x3 3Hk .018 Kt
• 00652221151711: Clarity(TM) SL Self-Ligating Bracket APC(TM) PLUS High Torque VPO UR4,5 -4T/0A Hk .022 5/Pk
• 00652221151704: Clarity(TM) SL Self-Ligating Bracket APC(TM) PLUS High Torque VPO UL4,5 -4T/0A Hk .022 5/Pk
• 00652221151698: Clarity(TM) SL Self-Ligating Bracket APC(TM) PLUS High Torque VPO UR3 6T/8A Hk .022 5/Pk
• 00652221151681: Clarity(TM) SL Self-Ligating Bracket APC(TM) PLUS High Torque VPO UR2 15T/9A .022 5/Pk
• 00652221151674: Clarity(TM) SL Self-Ligating Bracket APC(TM) PLUS High Torque VPO UL2 15T/9A .022 5/Pk
• 00652221151667: Clarity(TM) SL Self-Ligating Bracket APC(TM) PLUS MBT(TM) UR1 22T/4A .022 5/Pk
• 00652221151650: Clarity(TM) SL Self-Ligating Bracket APC(TM) PLUS MBT(TM) UL1 22T/4A .022 5/Pk
• 00652221151643: Clarity(TM) SL Self-Ligating Bracket APC(TM) PLUS High Torque VPO UR1 22T/5A .022 5/Pk
• 00652221151636: Clarity(TM) SL Self-Ligating Bracket APC(TM) PLUS High Torque VPO UL1 22T/5A .022 5/Pk
• 00652221151629: Clarity(TM) SL Self-Ligating Bracket APC(TM) PLUS High Torque VPO UR4,5 -4T/0A Hk .018 5/Pk
• 00652221151612: Clarity(TM) SL Self-Ligating Bracket APC(TM) PLUS High Torque VPO UL4,5 -4T/0A Hk .018 5/Pk
• 00652221151605: Clarity(TM) SL Self-Ligating Bracket APC(TM) PLUS High Torque VPO UR3 6T/8A Hk .018 5/Pk
• 00652221151599: Clarity(TM) SL Self-Ligating Bracket APC(TM) PLUS High Torque VPO UL3 6T/8A Hk .018 5/Pk
• 00652221151582: Clarity(TM) SL Self-Ligating Bracket APC(TM) PLUS High Torque VPO UR2 15T/9A .018 5/Pk
• 00652221151575: Clarity(TM) SL Self-Ligating Bracket APC(TM) PLUS High Torque VPO UL2 15T/9A .018 5/Pk
• 00652221151544: Clarity(TM) SL Self-Ligating Bracket APC(TM) PLUS High Torque VPO UR1 22T/5A .018 5/Pk
• 00652221151537: Clarity(TM) SL Self-Ligating Bracket APC(TM) PLUS High Torque VPO UL1 22T/5A .018 5/Pk
• 00652221149268: Clarity(TM) SL Self-Ligating Bracket APC(TM) PLUS MBT(TM) U/L 3X3 3Hk .018 Kt
• 00652221147493: Clarity(TM) SL Self-Ligating Bracket APC(TM) PLUS MBT(TM) U/L 3x3 3Hk .022 Kt
• 00652221142054: Clarity(TM) SL Self-Ligating Bracket APC(TM) PLUS Roth U 3x3 3Hk .022 Kt
• 00652221142023: Clarity(TM) SL Self-Ligating Bracket APC(TM) PLUS MBT(TM) U 3x3 3Hk .022 Kt
• 00652221141989: Clarity(TM) SL Self-Ligating Bracket APC(TM) PLUS MBT(TM) U 5x5 3Hk .022 Kt
• 00652221141972: Clarity(TM) SL Self-Ligating Bracket APC(TM) PLUS Roth U 3x3 3Hk .018 Kt
• 00652221139450: Clarity(TM) SL Self-Ligating Bracket APC(TM) PLUS MBT(TM) U 3x3 3Hk .018 Kt
• 00652221139443: Clarity(TM) SL Self-Ligating Bracket APC(TM) PLUS MBT(TM) U 5x5 3Hk .018 Kt
• 00652221138965: Clarity(TM) SL Self-Ligating Bracket APC(TM) PLUS MBT(TM) LR5 -17T/2A .018 5/Pk
• 00652221138958: Clarity(TM) SL Self-Ligating Bracket APC(TM) PLUS MBT(TM) LL5 -17T/2A .018 5/Pk
• 00652221138941: Clarity(TM) SL Self-Ligating Bracket APC(TM) PLUS MBT(TM) LR4 -12T/2A .018 5/Pk
• 00652221138934: Clarity(TM) SL Self-Ligating Bracket APC(TM) PLUS MBT(TM) LL4 -12T/2A .018 5/Pk
• 00652221138866: Clarity(TM) SL Self-Ligating Bracket APC(TM) PLUS MBT(TM) LR3 0T/3A Hk .018 5/Pk
• 00652221138859: Clarity(TM) SL Self-Ligating Bracket APC(TM) PLUS MBT(TM) LL3 0T/3A Hk .018 5/Pk
• 00652221138842: Clarity(TM) SL Self-Ligating Bracket APC(TM) PLUS MBT(TM) L1,2 -6T/0A .018 5/Pk
• 00652221138828: Clarity(TM) SL Self-Ligating Bracket APC(TM) PLUS MBT(TM) LR5 -17T/2A .022 5/Pk
• 00652221138811: Clarity(TM) SL Self-Ligating Bracket APC(TM) PLUS MBT(TM) LL5 -17T/2A .022 5/Pk
• 00652221138804: Clarity(TM) SL Self-Ligating Bracket APC(TM) PLUS MBT(TM) LR4 -12T/2A .022 5/Pk
• 00652221138798: Clarity(TM) SL Self-Ligating Bracket APC(TM) PLUS MBT(TM) LL4 -12T/2A .022 5/Pk
• 00652221138729: Clarity(TM) SL Self-Ligating Bracket APC(TM) PLUS MBT(TM) LR3 0T/3A Hk .022 5/Pk
• 00652221138712: Clarity(TM) SL Self-Ligating Bracket APC(TM) PLUS MBT(TM) LL3 0T/3A Hk .022 5/Pk
• 00652221138705: Clarity(TM) SL Self-Ligating Bracket APC(TM) PLUS MBT(TM) L1,2 -6T/0A .022 5/Pk
• 00652221134820: Clarity(TM) SL Self-Ligating Bracket APC(TM) PLUS Roth U 5x5 3Hk .022 Kt
• 00652221134462: Clarity(TM) SL Self-Ligating Bracket APC(TM) PLUS Roth U 5x5 3,4,5Hk .018 Kt
• 00652221121776: Clarity(TM) SL Self-Ligating Bracket APC(TM) PLUS MBT(TM) U 5x5 3,4,5Hk .022 Kt
• 00652221121769: Clarity(TM) SL Self-Ligating Bracket APC(TM) PLUS MBT(TM) U 5x5 .022 Kt
• 00652221121745: Clarity(TM) SL Self-Ligating Bracket APC(TM) PLUS MBT(TM) U 5x5 3,4,5Hk .018 Kt
• 00652221121738: Clarity(TM) SL Self-Ligating Bracket APC(TM) PLUS MBT(TM) U 5x5 .018 Kt
• 00652221121677: Clarity(TM) SL Self-Ligating Bracket APC(TM) PLUS MBT(TM) U/L 5x5 3Hk .022 Kt
• 00652221121639: Clarity(TM) SL Self-Ligating Bracket APC(TM) PLUS MBT(TM) U/L 5x5 3Hk .018 Kt