Clarity™ SL 007-421

GUDID 00652221004246

Clarity(TM) SL Self-Ligating Bracket Roth UL3 -2T/9A Hk .022 5/Pk

3M UNITEK CORPORATION

Orthodontic bracket, ceramic

• Primary Device ID: 00652221004246
• NIH Device Record Key: 08863a63-3e97-408a-b6c9-4743c2a887d6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Clarity™ SL
• Version Model Number: 007-421
• Catalog Number: 007-421
• 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: false
• 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	00652221004246 [Primary]
GS1	80652221004242 [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 [Clarity™ SL]

• 00652221151773: Clarity(TM) SL Self-Ligating Bracket High Torque VPO U 3x3 3Hk .022 Kt
• 00652221151766: Clarity(TM) SL Self-Ligating Bracket High Torque VPO U 3x3 3Hk .018 Kt
• 00652221150394: Clarity(TM) SL Self-Ligating Bracket High Torque VPO UR4,5 -4T/0A Hk .022 5/Pk
• 00652221150387: Clarity(TM) SL Self-Ligating Bracket High Torque VPO UL4,5 -4T/0A Hk .022 5/Pk
• 00652221150370: Clarity(TM) SL Self-Ligating Bracket High Torque VPO UR3 6T/8A Hk .022 5/Pk
• 00652221150363: Clarity(TM) SL Self-Ligating Bracket High Torque VPO UL3 6T/8A Hk .022 5/Pk
• 00652221150356: Clarity(TM) SL Self-Ligating Bracket High Torque VPO UR2 15T/9A .022 5/Pk
• 00652221150349: Clarity(TM) SL Self-Ligating Bracket High Torque VPO UL2 15T/9A .022 5/Pk
• 00652221150332: Clarity(TM) SL Self-Ligating Bracket MBT(TM) UR1 22T/4A .022 5/Pk
• 00652221150325: Clarity(TM) SL Self-Ligating Bracket MBT(TM) UL1 22T/4A .022 5/Pk
• 00652221150318: Clarity(TM) SL Self-Ligating Bracket High Torque VPO UR1 22T/5A .022 5/Pk
• 00652221150080: Clarity(TM) SL Self-Ligating Bracket High Torque VPO UL1 22T/5A .022 5/Pk
• 00652221150073: Clarity(TM) SL Self-Ligating Bracket High Torque VPO UR4,5 -4T/0A Hk .018 5/Pk
• 00652221150066: Clarity(TM) SL Self-Ligating Bracket High Torque VPO UL4,5 -4T/0A Hk .018 5/Pk
• 00652221150059: Clarity(TM) SL Self-Ligating Bracket High Torque VPO UR3 6T/8A Hk .018 5/Pk
• 00652221150042: Clarity(TM) SL Self-Ligating Bracket High Torque VPO UL3 6T/8A Hk .018 5/Pk
• 00652221150035: Clarity(TM) SL Self-Ligating Bracket High Torque VPO UR2 15T/9A .018 5/Pk
• 00652221150028: Clarity(TM) SL Self-Ligating Bracket High Torque VPO UL2 15T/9A .018 5/Pk
• 00652221149992: Clarity(TM) SL Self-Ligating Bracket High Torque VPO UR1 22T/5A .018 5/Pk
• 00652221149985: Clarity(TM) SL Self-Ligating Bracket High Torque VPO UL1 22T/5A .018 5/Pk
• 00652221149282: Clarity(TM) SL Self-Ligating Bracket MBT(TM) U/L 3x3 3Hk .018 Kt
• 00652221149251: Clarity(TM) SL Self-Ligating Bracket MBT(TM) U/L 5x5 3Hk .022 Kt
• 00652221147486: Clarity(TM) SL Self-Ligating Bracket MBT(TM) U/L 3x3 3Hk .022 Kt
• 00652221141897: Clarity(TM) SL Self-Ligating Bracket Roth U 5x5 3Hk .022 Kt
• 00652221139580: Clarity(TM) SL Self-Ligating Bracket Roth U 3x3 3Hk .022 Kt
• 00652221139573: Clarity(TM) SL Self-Ligating Bracket MBT(TM) U 3x3 3Hk .022 Kt
• 00652221139566: Clarity(TM) SL Self-Ligating Bracket MBT(TM) U 5x5 3Hk .022 Kt
• 00652221139559: Clarity(TM) SL Self-Ligating Bracket Roth U 5x5 3,4,5Hk .022 Kt
• 00652221139542: Clarity(TM) SL Self-Ligating Bracket Roth U 3x3 3Hk .018 Kt
• 00652221139504: Clarity(TM) SL Self-Ligating Bracket Roth U 5x5 3,4,5Hk .018 Kt
• 00652221139498: Clarity(TM) SL Self-Ligating Bracket MBT(TM) U 5x5 3,4,5Hk .022 Kt
• 00652221139467: Clarity(TM) SL Self-Ligating Bracket MBT(TM) U 5x5 3,4,5Hk .018 Kt
• 00652221139405: Clarity(TM) SL Self-Ligating Bracket MBT(TM) U 3x3 3Hk .018 Kt
• 00652221139399: Clarity(TM) SL Self-Ligating Bracket MBT(TM) U 5x5 3Hk .018 Kt
• 00652221139122: Clarity(TM) SL Self-Ligating Bracket MBT(TM) U/L 5x5 3Hk .018 Kt
• 00652221134813: Clarity(TM) SL Self-Ligating Bracket MBT(TM) LR5 -17T/2A .018 5/Pk
• 00652221134806: Clarity(TM) SL Self-Ligating Bracket MBT(TM) LL5 -17T/2A .018 5/Pk
• 00652221134790: Clarity(TM) SL Self-Ligating Bracket MBT(TM) LR4 -12T/2A .018 5/Pk
• 00652221134783: Clarity(TM) SL Self-Ligating Bracket MBT(TM) LL4 -12T/2A .018 5/Pk
• 00652221134714: Clarity(TM) SL Self-Ligating Bracket MBT(TM) LR3 0T/3A Hk .018 5/Pk
• 00652221134707: Clarity(TM) SL Self-Ligating Bracket MBT(TM) LL3 0T/3A Hk .018 5/Pk
• 00652221134691: Clarity(TM) SL Self-Ligating Bracket MBT(TM) L1,2 -6T/0A .018 5/Pk
• 00652221134677: Clarity(TM) SL Self-Ligating Bracket MBT(TM) LR5 -17T/2A .022 5/Pk
• 00652221134660: Clarity(TM) SL Self-Ligating Bracket MBT(TM) LL5 -17T/2A .022 5/Pk
• 00652221134653: Clarity(TM) SL Self-Ligating Bracket MBT(TM) LR4 -12T/2A .022 5/Pk
• 00652221134646: Clarity(TM) SL Self-Ligating Bracket MBT(TM) LL4 -12T/2A .022 5/Pk
• 00652221134561: Clarity(TM) SL Self-Ligating Bracket MBT(TM) LR3 0T/3A Hk .022 5/Pk
• 00652221134554: Clarity(TM) SL Self-Ligating Bracket MBT(TM) LL3 0T/3A Hk .022 5/Pk
• 00652221134547: Clarity(TM) SL Self-Ligating Bracket MBT(TM) L1,2 -6T/0A .022 5/Pk
• 00652221004536: Clarity(TM) SL Self-Ligating Bracket Roth UR4,5 -7T/0A Hk .018 5/Pk