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3M UNITEK Corporation

Matched from indexed company URL: 3M UNITEK CORPORATION

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
202046720204673M UNITEK Corporation1Y2026-01-012724 SOUTH PECK RD. MONROVIA CA US 91016

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
006522210018183M™ Unitek™ Metal Brackets - 001-227 STD Edge Twin V-Slot U/L Lt/Rt Cus/Bic 0T/0A 018+1(800)228-3957regulatoryrequests@solventum.com
006522210247323M™ Unitek™ Lingual Sheaths - 080-216 Lingual Sheaths Solid URt/LLt Hk+1(800)228-3957regulatoryrequests@solventum.com
006522210366983M™ Unitek™ Orthodontic Bands - 141-000 Bicuspid Band General Purpose Assorted+1(800)228-3957regulatoryrequests@solventum.com
006522210388693M™ Unitek™ Orthodontic Bands - 3M™ Unitek™ Bicuspid Band Proportional, 149-000+1(800)228-3957regulatoryrequests@solventum.com
006522210444403M™ Unitek™ Orthodontic Bands - Molar Band GP Regular U/L Lt/Rt Assorted+1(800)228-3957regulatoryrequests@solventum.com
006522210472503M™ Unitek™ - Contoured Bicuspid Mod Band Cab+1(800)228-3957regulatoryrequests@solventum.com
006522210472743M™ Unitek™ - Pro Lower Bicuspid Mod Band Cab+1(800)228-3957regulatoryrequests@solventum.com
006522210473803M™ Unitek™ - U 1st/2nd Molar Hard Swiss MBC+1(800)228-3957regulatoryrequests@solventum.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
57161440934030K9705003M SUSTEL DENTAL SYSTEMEBF1997-04-30
57161297490653K9627853M DENT SYSTEMKLE1996-08-12
57161806897764K950514TRI-CURE GLASS IONOMER ORTHODONTIC BAND CEMENTDYH1995-03-07
57161013670435K944286METAL-LINED TRANSCEND CERAMIC BRACKETDYW1994-11-29
57161680458036K911271ADHESIVE PRECOATED BRACKETSDYH1991-05-29
57161833546931K880393TRANSBOND LIGHT CURED ORTHODONTIC ADHESIVEDYH1988-03-31
57161860426448K813180SCOTCHBOND DENTAL ADHESIVEKLE1982-01-12
57161661299852K1921193M Clarity AlignersNXC2019-09-05
57161052322322K1804043M Clarity Ultra Self-Ligating Brackets and Adhesive Coated Appliance SystemNJM2018-03-16
57161237588615K113197APC FLASH-FREE ADHESIVEDYH2012-02-02
57161700827080K102803CLARITY ADVANCED CERAMIC BRACKETSNJM2011-02-17
57161968302467K100536TRANSBOND IDB PRE-MIX CHEMICAL CARE ADHESIVEDYH2010-07-27
57162005751739K073697TRANSBOND SUPREME ADHESIVEDYH2008-02-15
57161295485609K062305CLARITY MODIFIED CERAMIC BRACKETSNJM2006-10-18
57161197806063K020394APC PLUS ADHESIVEDYH2002-04-12
57161434779412K014142UNITE BONDING ADHESIVEDYH2002-02-28
57161616152220K011154ELIPAR FREELIGHTEBZ2001-05-16
57161323822647K001494MODIFICATION TO PROMPT L-POPKLE2000-07-07
57161037414381
57161044585467
57161095256412
57161154703436
57161192783464
57161273492348
57161285045002
57161295406073
57161321820533
57161335243815
57161414129715
57161422424293
57161473948854
57161484724185
57161608850424
57161640817876
57161644839448
57161699242389
57161751383231
57161813441284
57161841568506
57161875241499
57161896222144
57162014949680
57162035791147
57162058902719
57162062623014

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
DYH82012-02-02
NJM32018-03-16
KLE32000-07-07
NXC12019-09-05
EBZ12001-05-16
EBF11997-04-30
DYW11994-11-29

PMN#

GUDID#

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