APC™ Flash-Free Clarity™ SL 4007-521

GUDID 00652221164100

Clarity(TM) SL Self-Ligating Bracket APC(TM) Flash-Free Roth UL3 -2T/9A Hk .018 5/Pk

3M UNITEK CORPORATION

Orthodontic bracket, ceramic
Primary Device ID00652221164100
NIH Device Record Key853a2c64-4028-4f0f-9f22-f0828a3121a7
Commercial Distribution StatusIn Commercial Distribution
Brand NameAPC™ Flash-Free Clarity™ SL
Version Model Number4007-521
Catalog Number4007-521
Company DUNS008256356
Company Name3M UNITEK CORPORATION
Device Count5
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)423-4588
Email3Mhealthcarecompliance@mmm.com
Phone+1(800)423-4588
Email3Mhealthcarecompliance@mmm.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100652221164100 [Primary]
GS180652221164106 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NJMBracket, ceramic, orthodontic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-24

On-Brand Devices [APC™ Flash-Free Clarity™ SL]

00652221165916Clarity(TM) SL Self-Ligating Bracket APC(TM) Flash-Free High Torque VPO U 3x3 3Hk .022 Kt
00652221165909Clarity(TM) SL Self-Ligating Bracket APC(TM) Flash-Free High Torque VPO U 3x3 3Hk .018 Kt
00652221165893Clarity(TM) SL Self-Ligating Bracket APC(TM) Flash-Free High Torque VPO U 5x5 3Hk .022 Kt
00652221165886Clarity(TM) SL Self-Ligating Bracket APC(TM) Flash-Free High Torque VPO U 5x5 3,4,5Hk .018 Kt
00652221165879Clarity(TM) SL Self-Ligating Bracket APC(TM) Flash-Free MBT(TM) U/L 3x3 3Hk .022 Kt
00652221165862Clarity(TM) SL Self-Ligating Bracket APC(TM) Flash-Free MBT(TM) U 3x3 3Hk .022 Kt
00652221165855Clarity(TM) SL Self-Ligating Bracket APC(TM) Flash-Free MBT(TM) U 5x5 3Hk .022 Kt
00652221165848Clarity(TM) SL Self-Ligating Bracket APC(TM) Flash-Free MBT(TM) U/L 3X3 3Hk .018 Kt
00652221165831Clarity(TM) SL Self-Ligating Bracket APC(TM) Flash-Free MBT(TM) U 3x3 3Hk .018 Kt
00652221165824Clarity(TM) SL Self-Ligating Bracket APC(TM) Flash-Free MBT(TM) U 5x5 3Hk .018 Kt
00652221165817Clarity(TM) SL Self-Ligating Bracket APC(TM) Flash-Free MBT(TM) U 5x5 3,4,5Hk .022 Kt
00652221165800Clarity(TM) SL Self-Ligating Bracket APC(TM) Flash-Free MBT(TM) U 5x5 .022 Kt
00652221165770Clarity(TM) SL Self-Ligating Bracket APC(TM) Flash-Free MBT(TM) U/L 5x5 3Hk .022 Kt
00652221165763Clarity(TM) SL Self-Ligating Bracket APC(TM) Flash-Free MBT(TM) U 5x5 3,4,5Hk .018 Kt
00652221165756Clarity(TM) SL Self-Ligating Bracket APC(TM) Flash-Free MBT(TM) U 5x5 .018 Kt
00652221165725Clarity(TM) SL Self-Ligating Bracket APC(TM) Flash-Free MBT(TM) U/L 5x5 3Hk .018 Kt
00652221165718Clarity(TM) SL Self-Ligating Bracket APC(TM) Flash-Free Roth U/L 3x3 3Hk .022 Kt
00652221165701Clarity(TM) SL Self-Ligating Bracket APC(TM) Flash-Free Roth U 3x3 3Hk .022 Kt
00652221165695Clarity(TM) SL Self-Ligating Bracket APC(TM) Flash-Free Roth U 5x5 3Hk .022 Kt
00652221165688Clarity(TM) SL Self-Ligating Bracket APC(TM) Flash-Free Roth U 5x5 3,4,5Hk .022 Kt
00652221165671Clarity(TM) SL Self-Ligating Bracket APC(TM) Flash-Free Roth U/L 3x3 3Hk .018 Kt
00652221165664Clarity(TM) SL Self-Ligating Bracket APC(TM) Flash-Free Roth U 3x3 3Hk .018 Kt
00652221165657Clarity(TM) SL Self-Ligating Bracket APC(TM) Flash-Free Roth U 5x5 3Hk .018 Kt
00652221165640Clarity(TM) SL Self-Ligating Bracket APC(TM) Flash-Free Roth U 5x5 3,4,5Hk .018 Kt
00652221164131Clarity(TM) SL Self-Ligating Bracket APC(TM) Flash-Free Roth UR4,5 -7T/0A Hk .018 5/Pk
00652221164124Clarity(TM) SL Self-Ligating Bracket APC(TM) Flash-Free Roth UL4,5 -7T/0A Hk .018 5/Pk
00652221164117Clarity(TM) SL Self-Ligating Bracket APC(TM) Flash-Free Roth UR3 -2T/9A Hk .018 5/Pk
00652221164100Clarity(TM) SL Self-Ligating Bracket APC(TM) Flash-Free Roth UL3 -2T/9A Hk .018 5/Pk
00652221164094Clarity(TM) SL Self-Ligating Bracket APC(TM) Flash-Free Roth UR2 8T/9A .018 5/Pk
00652221164087Clarity(TM) SL Self-Ligating Bracket APC(TM) Flash-Free Roth UL2 8T/9A .018 5/Pk
00652221164070Clarity(TM) SL Self-Ligating Bracket APC(TM) Flash-Free Roth UR1 12T/5A .018 5/Pk
00652221164063Clarity(TM) SL Self-Ligating Bracket APC(TM) Flash-Free Roth UL1 12T/5A .018 5/Pk
00652221164025Clarity(TM) SL Self-Ligating Bracket APC(TM) Flash-Free Roth UR4,5 -7T/0A Hk .022 5/Pk
00652221164018Clarity(TM) SL Self-Ligating Bracket APC(TM) Flash-Free Roth UL4,5 -7T/0A Hk .022 5/Pk
00652221164001Clarity(TM) SL Self-Ligating Bracket APC(TM) Flash-Free Roth UR3 -2T/9A Hk .022 5/Pk
00652221163998Clarity(TM) SL Self-Ligating Bracket APC(TM) Flash-Free Roth UL3 -2T/9A Hk .022 5/Pk
00652221163981Clarity(TM) SL Self-Ligating Bracket APC(TM) Flash-Free Roth UR2 8T/9A .022 5/Pk
00652221163974Clarity(TM) SL Self-Ligating Bracket APC(TM) Flash-Free Roth UL2 8T/9A .022 5/Pk
00652221163967Clarity(TM) SL Self-Ligating Bracket APC(TM) Flash-Free Roth UR1 12T/5A .022 5/Pk
00652221163950Clarity(TM) SL Self-Ligating Bracket APC(TM) Flash-Free Roth UL1 12T/5A .022 5/Pk
00652221163943Clarity(TM) SL Self-Ligating Bracket APC(TM) Flash-Free High Torque VPO UR4,5 -4T/0A Hk .018 5/P
00652221163936Clarity(TM) SL Self-Ligating Bracket APC(TM) Flash-Free High Torque VPO UL4,5 -4T/0A Hk .018 5/P
00652221163929Clarity(TM) SL Self-Ligating Bracket APC(TM) Flash-Free High Torque VPO UR3 6T/8A Hk .018 5/Pk
00652221163912Clarity(TM) SL Self-Ligating Bracket APC(TM) Flash-Free High Torque VPO UL3 6T/8A Hk .018 5/Pk
00652221163905Clarity(TM) SL Self-Ligating Bracket APC(TM) Flash-Free High Torque VPO UR2 15T/9A .018 5/Pk
00652221163899Clarity(TM) SL Self-Ligating Bracket APC(TM) Flash-Free High Torque VPO UL2 15T/9A .018 5/Pk
00652221163868Clarity(TM) SL Self-Ligating Bracket APC(TM) Flash-Free High Torque VPO UR1 22T/5A .018 5/Pk
00652221163851Clarity(TM) SL Self-Ligating Bracket APC(TM) Flash-Free High Torque VPO UL1 22T/5A .018 5/Pk
00652221163844Clarity(TM) SL Self-Ligating Bracket APC(TM) Flash-Free MBT(TM) LR5 -17T/2A .018 5/Pk
00652221163837Clarity(TM) SL Self-Ligating Bracket APC(TM) Flash-Free MBT(TM) LL5 -17T/2A .018 5/Pk
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