3M™ Unitek™ SmartClip™ MBT™ 004-213

GUDID 00652221003034

SmartClip(TM) Self-Ligating Bracket MBT(TM) UL3 0T/8A Hk .018 5/Pk

3m do Brasil Ltda.

Orthodontic bracket, metal
Primary Device ID00652221003034
NIH Device Record Keyd9551d27-f870-4941-9cee-17d98aab008f
Commercial Distribution StatusIn Commercial Distribution
Brand Name3M™ Unitek™ SmartClip™ MBT™
Version Model Number004-213
Catalog Number004-213
Company DUNS901611820
Company Name3m do Brasil Ltda.
Device Count5
DM Exemptfalse
Pre-market Exempttrue
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 Datefalse
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
GS100652221003034 [Primary]
GS180652221003030 [Unit of Use]

FDA Product Code

EJFBRACKET, METAL, ORTHODONTIC

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-10-25
Device Publish Date2018-09-24

On-Brand Devices [3M™ Unitek™ SmartClip™ MBT™]

00652221144430SmartClip(TM) Bondable MBT(TM) UR6 -14T/10Off .022 5/Pk
00652221144348SmartClip(TM) Bondable MBT(TM) LR6 -20T/0Off .022 5/Pk
00652221144331SmartClip(TM) Bondable MBT(TM) LL6 -20T/0Off .022 5/Pk
00652221144324SmartClip(TM) Bondable MBT(TM) UL6 -14T/10Off .022 5/Pk
00652221144317SmartClip(TM) Bondable MBT(TM) LR6 -20T/0Off .018 5/Pk
00652221144300SmartClip(TM) Bondable MBT(TM) LL6 -20T/0Off .018 5/Pk
00652221144294SmartClip(TM) Bondable MBT(TM) UR6 -14T/10Off .018 5/Pk
00652221144287SmartClip(TM) Bondable MBT(TM) UL6 -14T/10Off .018 5/Pk
00652221135001SmartClip(TM) Self-Ligating Bracket MBT(TM)/High Torque VPO UR1 22T/4A .018 5/Pk
00652221134998SmartClip(TM) Self-Ligating Bracket MBT(TM)/High Torque VPO UL1 22T/4A .018 5/Pk
00652221003966SmartClip(TM) Self-Ligating Bracket MBT(TM) LR5 -17T/2A OffsetBase Hk .022 5/Pk
00652221003959SmartClip(TM) Self-Ligating Bracket MBT(TM) LR5 -17T/2A Hk .022 5/Pk
00652221003942SmartClip(TM) Self-Ligating Bracket MBT(TM) LL5 -17T/2A OffsetBase Hk .022 5/Pk
00652221003935SmartClip(TM) Self-Ligating Bracket MBT(TM) LL5 -17T/2A Hk .022 5/Pk
00652221003928SmartClip(TM) Self-Ligating Bracket MBT(TM) LR5 -17T/2A OffsetBase .022 5/Pk
00652221003911SmartClip(TM) Self-Ligating Bracket MBT(TM) LR5 -17T/2A .022 5/Pk
00652221003904SmartClip(TM) Self-Ligating Bracket MBT(TM) LL5 -17T/2A OffsetBase .022 5/Pk
00652221003898SmartClip(TM) Self-Ligating Bracket MBT(TM) LL5 -17T/2A .022 5/Pk
00652221003881SmartClip(TM) Self-Ligating Bracket MBT(TM) LR4 -12T/2A OffsetBase Hk .022 5/Pk
00652221003874SmartClip(TM) Self-Ligating Bracket MBT(TM) LR4 -12T/2A Hk .022 5/Pk
00652221003867SmartClip(TM) Self-Ligating Bracket MBT(TM) LL4 -12T/2A OffsetBase Hk .022 5/Pk
00652221003850SmartClip(TM) Self-Ligating Bracket MBT(TM) LL4 -12T/2A Hk .022 5/Pk
00652221003843SmartClip(TM) Self-Ligating Bracket MBT(TM) LR4 -12T/2A OffsetBase .022 5/Pk
00652221003836SmartClip(TM) Self-Ligating Bracket MBT(TM) LR4 -12T/2A .022 5/Pk
00652221003829SmartClip(TM) Self-Ligating Bracket MBT(TM) LL4 -12T/2A OffsetBase .022 5/Pk
00652221003812SmartClip(TM) Self-Ligating Bracket MBT(TM) LL4 -12T/2A .022 5/Pk
00652221003805SmartClip(TM) Self-Ligating Bracket MBT(TM) LR3 0T/3A Hk .022 5/Pk
00652221003799SmartClip(TM) Self-Ligating Bracket MBT(TM) LL3 0T/3A Hk .022 5/Pk
00652221003782SmartClip(TM) Self-Ligating Bracket MBT(TM) LR3 0T/3A .022 5/Pk
00652221003775SmartClip(TM) Self-Ligating Bracket MBT(TM) LL3 0T/3A .022 5/Pk
00652221003768SmartClip(TM) Self-Ligating Bracket MBT(TM) LR3 -6T/3A Hk .022 5/Pk
00652221003751SmartClip(TM) Self-Ligating Bracket MBT(TM) LL3 -6T/3A Hk .022 5/Pk
00652221003744SmartClip(TM) Self-Ligating Bracket MBT(TM) LR3 -6T/3A .022 5/Pk
00652221003737SmartClip(TM) Self-Ligating Bracket MBT(TM) LL3 -6T/3A .022 5/Pk
00652221003720SmartClip(TM) SL3 Self-Ligating Bracket MBT(TM) L1,2 -6T/0A .022 5/Pk
00652221003638SmartClip(TM) Self-Ligating Bracket MBT(TM) UR4,5 -7T/0A OffsetBase Hk .022 5/Pk
00652221003621SmartClip(TM) Self-Ligating Bracket MBT(TM) UR4,5 -7T/0A Hk .022 5/Pk
00652221003614SmartClip(TM) Self-Ligating Bracket MBT(TM) UL4,5 -7T/0A OffsetBase Hk .022 5/Pk
00652221003607SmartClip(TM) Self-Ligating Bracket MBT(TM) UL4,5 -7T/0A Hk .022 5/Pk
00652221003591SmartClip(TM) Self-Ligating Bracket MBT(TM) U4,5 -7T/0A OffsetBase .022 5/Pk
00652221003584SmartClip(TM) Self-Ligating Bracket MBT(TM) U4,5 -7T/0A .022 5/Pk
00652221003577SmartClip(TM) Self-Ligating Bracket MBT(TM) UR3 0T/8A Hk .022 5/Pk
00652221003560SmartClip(TM) Self-Ligating Bracket MBT(TM) UL3 0T/8A Hk .022 5/Pk
00652221003553SmartClip(TM) Self-Ligating Bracket MBT(TM) UR3 0T/8A .022 5/Pk
00652221003546SmartClip(TM) Self-Ligating Bracket MBT(TM) UL3 0T/8A .022 5/Pk
00652221003539SmartClip(TM) Self-Ligating Bracket MBT(TM) UR3 -7T/8A Hk .022 5/Pk
00652221003522SmartClip(TM) Self-Ligating Bracket MBT(TM) UL3 -7T/8A Hk .022 5/Pk
00652221003515SmartClip(TM) Self-Ligating Bracket MBT(TM) UR3 -7T/8A .022 5/Pk
00652221003508SmartClip(TM) Self-Ligating Bracket MBT(TM) UL3 -7T/8A .022 5/Pk
00652221003492SmartClip(TM) Self-Ligating Bracket MBT(TM) UR2 10T/8A .022 5/Pk
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