APC™ PLUS Unitek™ Miniature Twin 5017-312

GUDID 00652221086501

Unitek(TM) Miniature Twin Bracket APC(TM) PLUS Roth UR4,5 -7T/0A Hk .022 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 ID00652221086501
NIH Device Record Keydb8ce8bc-cbfe-4748-9fee-d54680fa4917
Commercial Distribution StatusIn Commercial Distribution
Brand NameAPC™ PLUS Unitek™ Miniature Twin
Version Model Number5017-312
Catalog Number5017-312
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
GS100652221086501 [Primary]
GS180652221086507 [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™ Miniature Twin]

00652221087591Unitek(TM) Miniature Twin Bracket APC(TM) PLUS Roth LR3 -11T/5A 6DistalRotation Hk .022 5/Pk
00652221087584Unitek(TM) Miniature Twin Bracket APC(TM) PLUS Roth LL3 -11T/5A 6DistalRotation Hk .022 5/Pk
00652221087577Unitek(TM) Miniature Twin Bracket APC(TM) PLUS Roth LR3 -11T/5A 6DistalRotation .022 5/Pk
00652221087560Unitek(TM) Miniature Twin Bracket APC(TM) PLUS Roth LL3 -11T/5A 6DistalRotation .022 5/Pk
00652221086792Unitek(TM) Miniature Twin Bracket APC(TM) PLUS Roth LR3 -11T/5A 6DistalRotation .018 5/Pk
00652221086785Unitek(TM) Miniature Twin Bracket APC(TM) PLUS Roth LL3 -11T/5A 6DistalRotation .018 5/Pk
00652221086617Unitek(TM) Miniature Twin Bracket APC(TM) PLUS Roth LR5 -22T/0A Hk .022 5/Pk
00652221086600Unitek(TM) Miniature Twin Bracket APC(TM) PLUS Roth LL5 -22T/0A Hk .022 5/Pk
00652221086594Unitek(TM) Miniature Twin Bracket APC(TM) PLUS Roth LR4 -17T/0A Hk .022 5/Pk
00652221086587Unitek(TM) Miniature Twin Bracket APC(TM) PLUS Roth LL4 -17T/0A Hk .022 5/Pk
00652221086570Unitek(TM) Miniature Twin Bracket APC(TM) PLUS Roth L5 -22T/0A .022 5/Pk
00652221086563Unitek(TM) Miniature Twin Bracket APC(TM) PLUS Roth L4 -17T/0A .022 5/Pk
00652221086556Unitek(TM) Miniature Twin Bracket APC(TM) PLUS Roth LR3 -11T/5A Hk .022 5/Pk
00652221086549Unitek(TM) Miniature Twin Bracket APC(TM) PLUS Roth LL3 -11T/5A Hk .022 5/Pk
00652221086532Unitek(TM) Miniature Twin Bracket APC(TM) PLUS Roth LR3 -11T/5A .022 5/Pk
00652221086525Unitek(TM) Miniature Twin Bracket APC(TM) PLUS Roth LL3 -11T/5A .022 5/Pk
00652221086518Unitek(TM) Miniature Twin Metal Bracket APC(TM) PLUS Roth L1,2 -1T/0A .022 5/Pk
00652221086501Unitek(TM) Miniature Twin Bracket APC(TM) PLUS Roth UR4,5 -7T/0A Hk .022 5/Pk
00652221086495Unitek(TM) Miniature Twin Bracket APC(TM) PLUS Roth UL4,5 -7T/0A Hk .022 5/Pk
00652221086488Unitek(TM) Miniature Twin Bracket APC(TM) PLUS Roth U4,5 -7T/0A .022 5/Pk
00652221086471Unitek(TM) Miniature Twin Bracket APC(TM) PLUS Roth UR3 0T/11A Hk .022 5/Pk
00652221086464Unitek(TM) Miniature Twin Bracket APC(TM) PLUS Roth UL3 0T/11A Hk .022 5/Pk
00652221086457Unitek(TM) Miniature Twin Bracket APC(TM) PLUS Roth UR3 0T/11A .022 5/Pk
00652221086440Unitek(TM) Miniature Twin Bracket APC(TM) PLUS Roth UL3 0T/11A .022 5/Pk
00652221086433Unitek(TM) Miniature Twin Bracket APC(TM) PLUS Roth UR2 8T/9A .022 5/Pk
00652221086426Unitek(TM) Miniature Twin Bracket APC(TM) PLUS Roth UL2 8T/9A .022 5/Pk
00652221086419Unitek(TM) Miniature Twin Bracket APC(TM) PLUS Roth UR1 12T/5A .022 5/Pk
00652221086402Unitek(TM) Miniature Twin Bracket APC(TM) PLUS Roth UL1 12T/5A .022 5/Pk
00652221086211Unitek(TM) Miniature Twin Bracket APC(TM) PLUS Roth LR5 -22T/0A Hk .018 5/Pk
00652221086204Unitek(TM) Miniature Twin Bracket APC(TM) PLUS Roth LL5 -22T/0A Hk .018 5/Pk
00652221086198Unitek(TM) Miniature Twin Bracket APC(TM) PLUS Roth LR4 -17T/0A Hk .018 5/Pk
00652221086181Unitek(TM) Miniature Twin Bracket APC(TM) PLUS Roth LL4 -17T/0A Hk .018 5/Pk
00652221086174Unitek(TM) Miniature Twin Bracket APC(TM) PLUS Roth L5 -22T/0A .018 5/Pk
00652221086167Unitek(TM) Miniature Twin Bracket APC(TM) PLUS Roth L4 -17T/0A .018 5/Pk
00652221086150Unitek(TM) Miniature Twin Bracket APC(TM) PLUS Roth LR3 -11T/5A Hk .018 5/Pk
00652221086143Unitek(TM) Miniature Twin Bracket APC(TM) PLUS Roth LL3 -11T/5A Hk .018 5/Pk
00652221086136Unitek(TM) Miniature Twin Bracket APC(TM) PLUS Roth LR3 -11T/5A .018 5/Pk
00652221086129Unitek(TM) Miniature Twin Bracket APC(TM) PLUS Roth LL3 -11T/5A .018 5/Pk
00652221086112Unitek(TM) Miniature Twin Metal Bracket APC(TM) PLUS Roth L1,2 -1T/0A .018 5/Pk
00652221086105Unitek(TM) Miniature Twin Bracket APC(TM) PLUS Roth UR4,5 -7T/0A Hk .018 5/Pk
00652221086099Unitek(TM) Miniature Twin Bracket APC(TM) PLUS Roth UL4,5 -7T/0A Hk .018 5/Pk
00652221086082Unitek(TM) Miniature Twin Bracket APC(TM) PLUS Roth U4,5 -7T/0A .018 5/Pk
00652221086075Unitek(TM) Miniature Twin Bracket APC(TM) PLUS Roth UR3 0T/11A Hk .018 5/Pk
00652221086068Unitek(TM) Miniature Twin Bracket APC(TM) PLUS Roth UL3 0T/11A Hk .018 5/Pk
00652221086051Unitek(TM) Miniature Twin Bracket APC(TM) PLUS Roth UR3 0T/11A .018 5/Pk
00652221086044Unitek(TM) Miniature Twin Bracket APC(TM) PLUS Roth UL3 0T/11A .018 5/Pk
00652221086037Unitek(TM) Miniature Twin Bracket APC(TM) PLUS Roth UR2 8T/9A .018 5/Pk
00652221086020Unitek(TM) Miniature Twin Bracket APC(TM) PLUS Roth UL2 8T/9A .018 5/Pk
00652221086013Unitek(TM) Miniature Twin Bracket APC(TM) PLUS Roth UR1 12T/5A .018 5/Pk
00652221086006Unitek(TM) Miniature Twin Bracket APC(TM) PLUS Roth UL1 12T/5A .018 5/Pk
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