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COLTENE/WHALEDENT AG

Matched from indexed company URL: Coltene/Whaledent AG

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
96133753002806620COLTENE/WHALEDENT AG1N2026-01-01FELDWIESENSTRASSE 20 ALTSTAETTEN Sankt Gallen CH CH-9450

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
07640181476947BRILLIANT EverGlow - Univ. Comp B-EA1+41717575300info.ch@coltene.com
07640181476954BRILLIANT EverGlow - Univ. Comp B-EA2+41717575300info.ch@coltene.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
252571937279390K994012TEMPOFIT, MODEL 02693EBG2000-02-16
252571756522846K993710MODIFICATION OF PARAPOST CEMENTEMA1999-12-21
252571272969087K974906ONE COAT BOND DENTIN/ENAMEL ADHESIVE SYSTEMKLE1998-03-24
252571877371947K974465SYNERGYEBF1998-03-09
252571933633451K945366PARAPOST CEMENTEMA1995-02-02
252571292183630K922615COLTENE A.R.T. BONDKLE1992-08-03
252571420481790K912485COLTENE PRESIDENT JET LIGHT/REG BODY HYDROPHILICELW1991-07-25
252572047817867K870266COLTENE BRILLIANT D.I. DIRECT INLAY SYSTEMEBF1987-02-27
252571038891357K870047COLTENE RAPIDELW1987-01-29
252571503057691K863998COLTENE JET-MIXEREID1986-10-30
252572065644011K850036COLTENE PRECISEELW1985-02-08
252571403904203K840297COLTENE ORALLOY MAGICAPSEJJ1984-03-16
252571031098010K840085COLTENE BRILLIANTEBF1984-03-16
252571158172933K840084COLTENE BRILLIANT LUXEBF1984-03-30
252571070487979K811767COLTENE PRESIDENT IMPRESSION MATERIALSELW1981-07-15
252571625346369K811667COLTENE PRESSURE SPOT INDICATORELW1981-07-15
252571807171196K811666COLTENE COLTEX/COLTOFLAXELW1981-07-15
252571541205568K810907COLTENE ORALLYEJJ1981-04-23
252571508425184K220097PRESIDENT The OriginalELW2022-01-13
252571244104051K191385BRILLIANT COMPONEEREBF2019-10-29
252571119379864K190597BRILLIANT EverGlow FlowEBF2019-06-21
252571651038507K181500BRILLIANT CriosEBF2018-08-15
252571855199229K173573Tetric CADEBF2018-06-07
252572025312443K160800DuoCemEMA2016-11-16
252571981812613K152927BRILLIANT EVERGLOWEBF2016-04-28
252571658386046K152243One Coat 7 UniversalKLE2015-12-09
252571082472866K150218Fill-Up!EBF2015-06-23
252571470373713K121621SOLOCEMEMA2013-01-08
252571178579161K112168COMPONEEREBF2011-11-21
252571499266966K083304TEMPOSIL 2EMA2009-02-06
252571846118780K072604DUO TEMPEMA2007-11-16
252571143043832K053040PARACEM UNIVERSAL DCEMA2005-11-09
252571419690037K052820PARAPOST PARACORE AUTOMIX 5MLEBF2006-01-09
252571791456588K051243JET BLUE BITEELW2005-06-23
252571951717806K050426TEMPOSIL, MODEL 6720EMA2005-03-18
252571787063884K050013RETRACTOFOAMELW2005-02-09
252571218498831K041098COOL TEMP NATURALEBG2004-05-13
252571519034362K033760ONE COAT SE BONDKLE2004-01-23
252571378859993K031752COLTOSOL FEMA2003-08-05
252571262859740K022224COOL BOND LIGHT CURED BRACKET ADHESIVE SYSTEMDYH2002-09-18
252571394488467K013400SYNERGY FLOWEBF2001-12-10
252571097402781K003034COLTENE AURA COMPOMER RESTORATIVE SYSTEMEBF2000-11-30
252571394164861
252571761942105
252571785434313
252571036253574
252571170696087
252571262085396
252571411375131
252571423554704
252571662469424
252571683804428
252571791079388

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
EBF142019-10-29
ELW92022-01-13
EMA92016-11-16
KLE42015-12-09
EBG22004-05-13
EJJ21984-03-16
DYH12002-09-18
EID11986-10-30

PMN#

GUDID#

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