APC™ II Clarity™ SL 3007-439

GUDID 00652221138521

Clarity(TM) SL Self-Ligating Bracket APC(TM) II MBT(TM) LL4 -12T/2A .022 5/Pk

3M UNITEK CORPORATION

Orthodontic bracket, ceramic
Primary Device ID00652221138521
NIH Device Record Key50cbe92a-886c-48de-b955-fa0d82206236
Commercial Distribution StatusIn Commercial Distribution
Brand NameAPC™ II Clarity™ SL
Version Model Number3007-439
Catalog Number3007-439
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
Phone+1(800)423-4588
Email3Mhealthcarecompliance@mmm.com
Phone+1(800)423-4588
Email3Mhealthcarecompliance@mmm.com
Phone+1(800)423-4588
Email3Mhealthcarecompliance@mmm.com
Phone+1(800)423-4588
Email3Mhealthcarecompliance@mmm.com
Phone+1(800)423-4588
Email3Mhealthcarecompliance@mmm.com
Phone+1(800)423-4588
Email3Mhealthcarecompliance@mmm.com
Phone+1(800)423-4588
Email3Mhealthcarecompliance@mmm.com
Phone+1(800)423-4588
Email3Mhealthcarecompliance@mmm.com
Phone+1(800)423-4588
Email3Mhealthcarecompliance@mmm.com
Phone+1(800)423-4588
Email3Mhealthcarecompliance@mmm.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100652221138521 [Primary]
GS180652221138527 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DYHADHESIVE, BRACKET AND TOOTH CONDITIONER, RESIN

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™ II Clarity™ SL]

00652221151889Clarity(TM) SL Self-Ligating Bracket APC(TM) II High Torque VPO U 3x3 3Hk .018 Kt
00652221151520Clarity(TM) SL Self-Ligating Bracket APC(TM) II High Torque VPO UR4,5 -4T/0A Hk .022 5/Pk
00652221151513Clarity(TM) SL Self-Ligating Bracket APC(TM) II High Torque VPO UL4,5 -4T/0A Hk .022 5/Pk
00652221151506Clarity(TM) SL Self-Ligating Bracket APC(TM) II High Torque VPO UR3 6T/8A Hk .022 5/Pk
00652221151490Clarity(TM) SL Self-Ligating Bracket APC(TM) II High Torque VPO UL3 6T/8A Hk .022 5/Pk
00652221151483Clarity(TM) SL Self-Ligating Bracket APC(TM) II High Torque VPO UR2 15T/9A .022 5/Pk
00652221151476Clarity(TM) SL Self-Ligating Bracket APC(TM) II High Torque VPO UL2 15T/9A .022 5/Pk
00652221151469Clarity(TM) SL Self-Ligating Bracket APC(TM) II MBT(TM) UR1 22T/4A .022 5/Pk
00652221151452Clarity(TM) SL Self-Ligating Bracket APC(TM) II MBT(TM) UL1 22T/4A .022 5/Pk
00652221151445Clarity(TM) SL Self-Ligating Bracket APC(TM) II High Torque VPO UR1 22T/5A .022 5/Pk
00652221151438Clarity(TM) SL Self-Ligating Bracket APC(TM) II High Torque VPO UL1 22T/5A .022 5/Pk
00652221151421Clarity(TM) SL Self-Ligating Bracket APC(TM) II High Torque VPO UR4,5 -4T/0A Hk .018 5/Pk
00652221151414Clarity(TM) SL Self-Ligating Bracket APC(TM) II High Torque VPO UL4,5 -4T/0A Hk .018 5/Pk
00652221151407Clarity(TM) SL Self-Ligating Bracket APC(TM) II High Torque VPO UR3 6T/8A Hk .018 5/Pk
00652221151391Clarity(TM) SL Self-Ligating Bracket APC(TM) II High Torque VPO UL3 6T/8A Hk .018 5/Pk
00652221151384Clarity(TM) SL Self-Ligating Bracket APC(TM) II High Torque VPO UR2 15T/9A .018 5/Pk
00652221151377Clarity(TM) SL Self-Ligating Bracket APC(TM) II High Torque VPO UL2 15T/9A .018 5/Pk
00652221151346Clarity(TM) SL Self-Ligating Bracket APC(TM) II High Torque VPO UR1 22T/5A .018 5/Pk
00652221151339Clarity(TM) SL Self-Ligating Bracket APC(TM) II High Torque VPO UL1 22T/5A .018 5/Pk
00652221149329Clarity(TM) SL Self-Ligating Bracket APC(TM) II MBT(TM) U/L 3x3 3Hk .022 Kt
00652221149275Clarity(TM) SL Self-Ligating Bracket APC(TM) II MBT(TM) U/L 3X3 3Hk .018 Kt
00652221141873Clarity(TM) SL Self-Ligating Bracket APC(TM) II Roth U 3x3 3Hk .022 Kt
00652221141866Clarity(TM) SL Self-Ligating Bracket APC(TM) II MBT(TM) U 3x3 3Hk .022 Kt
00652221141859Clarity(TM) SL Self-Ligating Bracket APC(TM) II MBT(TM) U 5x5 3Hk .022 Kt
00652221141842Clarity(TM) SL Self-Ligating Bracket APC(TM) II Roth U 3x3 3Hk .018 Kt
00652221139436Clarity(TM) SL Self-Ligating Bracket APC(TM) II MBT(TM) U 3x3 3Hk .018 Kt
00652221139429Clarity(TM) SL Self-Ligating Bracket APC(TM) II MBT(TM) U 5x5 3Hk .018 Kt
00652221139146Clarity(TM) SL Self-Ligating Bracket APC(TM) II MBT(TM) LR3 0T/3A Hk .018 5/Pk
00652221138682Clarity(TM) SL Self-Ligating Bracket APC(TM) II MBT(TM) LR5 -17T/2A .018 5/Pk
00652221138675Clarity(TM) SL Self-Ligating Bracket APC(TM) II MBT(TM) LL5 -17T/2A .018 5/Pk
00652221138668Clarity(TM) SL Self-Ligating Bracket APC(TM) II MBT(TM) LR4 -12T/2A .018 5/Pk
00652221138651Clarity(TM) SL Self-Ligating Bracket APC(TM) II MBT(TM) LL4 -12T/2A .018 5/Pk
00652221138583Clarity(TM) SL Self-Ligating Bracket APC(TM) II MBT(TM) LL3 0T/3A Hk .018 5/Pk
00652221138576Clarity(TM) SL Self-Ligating Bracket APC(TM) II MBT(TM) L1,2 -6T/0A .018 5/Pk
00652221138552Clarity(TM) SL Self-Ligating Bracket APC(TM) II MBT(TM) LR5 -17T/2A .022 5/Pk
00652221138545Clarity(TM) SL Self-Ligating Bracket APC(TM) II MBT(TM) LL5 -17T/2A .022 5/Pk
00652221138538Clarity(TM) SL Self-Ligating Bracket APC(TM) II MBT(TM) LR4 -12T/2A .022 5/Pk
00652221138521Clarity(TM) SL Self-Ligating Bracket APC(TM) II MBT(TM) LL4 -12T/2A .022 5/Pk
00652221138460Clarity(TM) SL Self-Ligating Bracket APC(TM) II MBT(TM) LR3 0T/3A Hk .022 5/Pk
00652221138453Clarity(TM) SL Self-Ligating Bracket APC(TM) II MBT(TM) LL3 0T/3A Hk .022 5/Pk
00652221138446Clarity(TM) SL Self-Ligating Bracket APC(TM) II MBT(TM) L1,2 -6T/0A .022 5/Pk
00652221134981Clarity(TM) SL Self-Ligating Bracket APC(TM) II Roth U 5x5 3Hk .022 Kt
00652221134523Clarity(TM) SL Self-Ligating Bracket APC(TM) II Roth U 5x5 3,4,5Hk .022 Kt
00652221122070Clarity(TM) SL Self-Ligating Bracket APC(TM) II MBT(TM) U 5x5 .022 Kt
00652221121622Clarity(TM) SL Self-Ligating Bracket APC(TM) II MBT(TM) U 5x5 3,4,5Hk .022 Kt
00652221121592Clarity(TM) SL Self-Ligating Bracket APC(TM) II MBT(TM) U 5x5 3,4,5Hk .018 Kt
00652221121523Clarity(TM) SL Self-Ligating Bracket APC(TM) II MBT(TM) U/L 5x5 3Hk .022 Kt
00652221121486Clarity(TM) SL Self-Ligating Bracket APC(TM) II MBT(TM) U/L 5x5 3Hk .018 Kt
00652221121400Clarity(TM) SL Self-Ligating Bracket APC(TM) II Roth UR4,5 -7T/0A Hk .018 5/Pk
00652221121394Clarity(TM) SL Self-Ligating Bracket APC(TM) II Roth UL4,5 -7T/0A Hk .018 5/Pk
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