APC™ PLUS Unitek™ Mini Uni-Twin 5020-498

GUDID 00652221093196

Mini Uni-Twin(TM) Bracket APC(TM) PLUS Standard Edgewise UR4,5/LL4,5 0T/0A Hk .018 5/Pk

3M UNITEK CORPORATION

Orthodontic bracket, metal Orthodontic bracket, metal Orthodontic bracket, metal Orthodontic bracket, metal Orthodontic bracket, metal Orthodontic bracket, metal Orthodontic bracket, metal Orthodontic bracket, metal Orthodontic bracket, metal Orthodontic bracket, metal Orthodontic bracket, metal Orthodontic bracket, metal
Primary Device ID00652221093196
NIH Device Record Keyeda25375-c782-4621-b02f-d20232d22063
Commercial Distribution StatusIn Commercial Distribution
Brand NameAPC™ PLUS Unitek™ Mini Uni-Twin
Version Model Number5020-498
Catalog Number5020-498
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
GS100652221093196 [Primary]
GS180652221093192 [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™ PLUS Unitek™ Mini Uni-Twin]

00652221094612Mini Uni-Twin(TM) Bracket APC(TM) PLUS LR3 0T/6A Hk .022 5/Pk
00652221094605Mini Uni-Twin(TM) Bracket APC(TM) PLUS LL3 0T/6A Hk .022 5/Pk
00652221094599Mini Uni-Twin(TM) Bracket APC(TM) PLUS LR3 -11T/5A Hk .022 5/Pk
00652221094582Mini Uni-Twin(TM) Bracket APC(TM) PLUS LL3 -11T/5A Hk .022 5/Pk
00652221094575Mini Uni-Twin(TM) Bracket APC(TM) PLUS LR3 0T/6A .022 5/Pk
00652221094568Mini Uni-Twin(TM) Bracket APC(TM) PLUS LL3 0T/6A .022 5/Pk
00652221094551Mini Uni-Twin(TM) Bracket APC(TM) PLUS LR3 -11T/5A .022 5/Pk
00652221094544Mini Uni-Twin(TM) Bracket APC(TM) PLUS LL3 -11T/5A .022 5/Pk
00652221094537Mini Uni-Twin(TM) Bracket APC(TM) PLUS LR5 -22T/0A OffsetBase Hk .022 5/Pk
00652221094520Mini Uni-Twin(TM) Bracket APC(TM) PLUS LR5 -22T/0A Hk .022 5/Pk
00652221094513Mini Uni-Twin(TM) Bracket APC(TM) PLUS LL5 -22T/0A OffsetBase Hk .022 5/Pk
00652221094506Mini Uni-Twin(TM) Bracket APC(TM) PLUS LL5 -22T/0A Hk .022 5/Pk
00652221094490Mini Uni-Twin(TM) Bracket APC(TM) PLUS LR4 -17T/0A OffsetBase Hk .022 5/Pk
00652221094483Mini Uni-Twin(TM) Bracket APC(TM) PLUS LR4 -17T/0A Hk .022 5/Pk
00652221094476Mini Uni-Twin(TM) Bracket APC(TM) PLUS LL4 -17T/0A OffsetBase Hk .022 5/Pk
00652221094469Mini Uni-Twin(TM) Bracket APC(TM) PLUS LL4 -17T/0A Hk .022 5/Pk
00652221094452Mini Uni-Twin(TM) Bracket APC(TM) PLUS L1,2 -1T/0A .022 5/Pk
00652221094445Mini Uni-Twin(TM) Bracket APC(TM) PLUS L5 -22T/0A OffsetBase .022 5/Pk
00652221094438Mini Uni-Twin(TM) Bracket APC(TM) PLUS L5 -22T/0A .022 5/Pk
00652221094421Mini Uni-Twin(TM) Bracket APC(TM) PLUS L4 -17T/0A OffsetBase .022 5/Pk
00652221094414Mini Uni-Twin(TM) Bracket APC(TM) PLUS L4 -17T/0A .022 5/Pk
00652221094391Mini Uni-Twin(TM) Bracket APC(TM) PLUS UL4,5 -7T/0A Hk .022 5/Pk
00652221094377Mini Uni-Twin(TM) Bracket APC(TM) PLUS UR4,5 -7T/0A Hk .022 5/Pk
00652221094360Mini Uni-Twin(TM) Bracket APC(TM) PLUS U4,5 -7T/0A OffsetBase .022 5/Pk
00652221094353Mini Uni-Twin(TM) Bracket APC(TM) PLUS U4,5 -7T/0A .022 5/Pk
00652221094346Mini Uni-Twin(TM) Bracket APC(TM) PLUS UR3 -7T/11A Hk .022 5/Pk
00652221094339Mini Uni-Twin(TM) Bracket APC(TM) PLUS UL3 -7T/11A Hk .022 5/Pk
00652221094322Mini Uni-Twin(TM) Bracket APC(TM) PLUS UR3 0T/11A Hk .022 5/Pk
00652221094315Mini Uni-Twin(TM) Bracket APC(TM) PLUS UL3 0T/11A Hk .022 5/Pk
00652221094308Mini Uni-Twin(TM) Bracket APC(TM) PLUS UR3 -7T/11A .022 5/Pk
00652221094292Mini Uni-Twin(TM) Bracket APC(TM) PLUS UL3 -7T/11A .022 5/Pk
00652221094285Mini Uni-Twin(TM) Bracket APC(TM) PLUS UR3 0T/11A .022 5/Pk
00652221094278Mini Uni-Twin(TM) Bracket APC(TM) PLUS UL3 0T/11A .022 5/Pk
00652221094261Mini Uni-Twin(TM) Bracket APC(TM) PLUS UR2 3T/9A .022 5/Pk
00652221094254Mini Uni-Twin(TM) Bracket APC(TM) PLUS UL2 3T/9A .022 5/Pk
00652221094247Mini Uni-Twin(TM) Bracket APC(TM) PLUS UR2 8T/9A .022 5/Pk
00652221094230Mini Uni-Twin(TM) Bracket APC(TM) PLUS UL2 8T/9A .022 5/Pk
00652221094223Mini Uni-Twin(TM) Bracket APC(TM) PLUS UR1 7T/5A .022 5/Pk
00652221094209Mini Uni-Twin(TM) Bracket APC(TM) PLUS Roth UR1 12T/5A .022 5/Pk
00652221094193Mini Uni-Twin(TM) Bracket APC(TM) PLUS Roth UL1 12T/5A .022 5/Pk
00652221094186Mini Uni-Twin(TM) Bracket APC(TM) PLUS UR3 0T/6A .018 5/Pk
00652221094179Mini Uni-Twin(TM) Bracket APC(TM) PLUS UL3 0T/6A .018 5/Pk
00652221094162Mini Uni-Twin(TM) Bracket APC(TM) PLUS LR3 0T/6A Hk .018 5/Pk
00652221094155Mini Uni-Twin(TM) Bracket APC(TM) PLUS LL3 0T/6A Hk .018 5/Pk
00652221094148Mini Uni-Twin(TM) Bracket APC(TM) PLUS LR3 -11T/5A Hk .018 5/Pk
00652221094131Mini Uni-Twin(TM) Bracket APC(TM) PLUS LL3 -11T/5A Hk .018 5/Pk
00652221094124Mini Uni-Twin(TM) Bracket APC(TM) PLUS LR3 0T/6A .018 5/Pk
00652221094117Mini Uni-Twin(TM) Bracket APC(TM) PLUS LL3 0T/6A .018 5/Pk
00652221094100Mini Uni-Twin(TM) Bracket APC(TM) PLUS LR3 -11T/5A .018 5/Pk
00652221094094Mini Uni-Twin(TM) Bracket APC(TM) PLUS LL3 -11T/5A .018 5/Pk
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