APC™ PLUS Clarity™ SL 5007-504

GUDID 00652221120281

Clarity(TM) SL Self-Ligating Bracket APC(TM) PLUS MBT(TM) UR2 10T/8A .018 5/Pk

3M UNITEK CORPORATION

Orthodontic bracket, ceramic
Primary Device ID00652221120281
NIH Device Record Keyfed40240-cfcc-4ff8-a08d-cb1b7d70e2ec
Commercial Distribution StatusIn Commercial Distribution
Brand NameAPC™ PLUS Clarity™ SL
Version Model Number5007-504
Catalog Number5007-504
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
GS100652221120281 [Primary]
GS180652221120287 [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™ PLUS Clarity™ SL]

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