FDA.reportPublic FDA data

COLTENE

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
24164552416455COLTENE/WHALEDENT INC.1Y2026-01-01235 Ascot Pkwy CUYAHOGA FALLS OH US 44223
80106293001180585COLTENE/WHALEDENT GMBH & CO. KG1N2026-01-01RAIFFEISENSTRASSE 30 LANGENAU Baden-Wurttemberg DE 89129
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
252562025573569K993835PARAPOST SYSTEM STERILIZABLE ORGANIZERFRG1999-12-16
252571756522846K993710MODIFICATION OF PARAPOST CEMENTEMA1999-12-21
252561938404118K993545TENAX WHITE POSTELR2000-04-14
252561459664220K990682PROPHY-MATE MOTOR HANDPIECE, MODELS PROPHY-MATE (2000 RPM MAX), ENDO-MATE (600RPM MAX.)EKX1999-03-24
202232054167971K990682PROPHY-MATE MOTOR HANDPIECE, MODELS PROPHY-MATE (2000 RPM MAX), ENDO-MATE (600RPM MAX.)EKX1999-03-24
252561905519288K983727BIOSONIC ULTRASONIC SCALER SYSTEMELC1999-01-20
202231764116160K983037ROEKO SEALKIF1998-10-20
252571272969087K974906ONE COAT BOND DENTIN/ENAMEL ADHESIVE SYSTEMKLE1998-03-24
252571877371947K974465SYNERGYEBF1998-03-09
202231346283704K973539ROEKO CALCIUM HYDROXIDE POINTSEJK1997-10-30
252571933633451K945366PARAPOST CEMENTEMA1995-02-02
252561203044242K934192PARAPOST XT SYSTEMELR1994-06-06
252562019772823K930764ENDO-ICE-PULP TESTER-THERMALEAT1993-05-27
252571292183630K922615COLTENE A.R.T. BONDKLE1992-08-03
252571420481790K912485COLTENE PRESIDENT JET LIGHT/REG BODY HYDROPHILICELW1991-07-25
252561161679324K911225TRAY DOUGHKGS1991-04-17
252561443176039K905640SOLID CORE GUTTA PERCHA CARRIEREKS1991-03-05
252561327672662K902392COLTOSOL TEMPORARY ENDODONTIC FILLING MATERIALEMA1990-08-28
252561011138851K900844WEDJETSEIE1990-04-16
252561908774433K900301NOVUS BONDING AGENTEBI1990-05-15
252562007248909K894092DENTAL ENDODONTIC CEMENT (MODIFICATION)KIF1990-01-10
252572047817867K870266COLTENE BRILLIANT D.I. DIRECT INLAY SYSTEMEBF1987-02-27
252571038891357K870047COLTENE RAPIDELW1987-01-29
252571503057691K863998COLTENE JET-MIXEREID1986-10-30
252561947004089K863393ENDOCATERLQY1987-06-11
202231036811484K850863ULTRAFIL-LT (GUTTA PERCHA)EKM1985-04-16
252561420757597K850863ULTRAFIL-LT (GUTTA PERCHA)EKM1985-04-16
252561282330235K850666STROBEX ULTRON ELECTROSURGE-DENTAL UNITEKZ1985-05-29
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
252561214246306K810026DENTAL ENDODONTIC CEMENTEMA1981-01-28
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
252561114622318K130137BIOSONIC SUVI PIEZEOELECTRIC SCALER AND POLISHERELC2013-08-23
252561053263133K123582ENDO A CLASSEKX2013-08-16
252571470373713K121621SOLOCEMEMA2013-01-08
252562025309141K121093D1 LED CURING LIGHT, SPEC 3, DENTRONIX LED 3000EBZ2012-11-27
252561594558854K112250CHX=CHX PLUSKJJ2011-10-28
252571178579161K112168COMPONEEREBF2011-11-21
252561357576908K111474BINGO PROLQY2011-11-02
252571499266966K083304TEMPOSIL 2EMA2009-02-06
252561963563425K082470SODIUM HYPOCHLORITE 3 & 6% SOLUTION AND 6% WITH WETTING AGENTS TO LOWER SURFACE TENSION MARKETED AS CHLOR-XTRAKJJ2009-04-03
252571846118780K072604DUO TEMPEMA2007-11-16
252561489923281K071632PERFECT TISSUE CONTOURING SYSTEM IIEKZ2007-10-18
252561137604911K053555ULTRASONIC SCALER, MODELS UDS-N1, UDS-N2. UDS-J, UDS-K, UDS-LELC2006-08-21
252571143043832K053040PARACEM UNIVERSAL DCEMA2005-11-09
252571419690037K052820PARAPOST PARACORE AUTOMIX 5MLEBF2006-01-09
252561996148973K051660DENTRONIX DDS 7000 RAPID DRY HEAT STERILIZER STERILIZATION SYSTEMKMH2005-08-04
252571791456588K051243JET BLUE BITEELW2005-06-23
252571951717806K050426TEMPOSIL, MODEL 6720EMA2005-03-18
252571787063884K050013RETRACTOFOAMELW2005-02-09
252571218498831K041098COOL TEMP NATURALEBG2004-05-13
202231438856629K041023STAY-PUT IMPREGNATEDMVL2004-06-15
252561815369885K040551COLTOLUX LED CURING LIGHTEBZ2004-03-15
252571519034362K033760ONE COAT SE BONDKLE2004-01-23
202231353753829K032662GUTTAFLOWKIF2003-11-03
252571378859993K031752COLTOSOL FEMA2003-08-05
252571262859740K022224COOL BOND LIGHT CURED BRACKET ADHESIVE SYSTEMDYH2002-09-18
252571394488467K013400SYNERGY FLOWEBF2001-12-10
252571097402781K003034COLTENE AURA COMPOMER RESTORATIVE SYSTEMEBF2000-11-30
252561097428589K000311PARAPOST FIBER WHITEELR2000-03-14
252561049426762
252561147041063
252561191770003
252561297911793
252561387686263
252571394164861
202231401541654
252561438440763
252561536247987
202231578683338
252561594065958
252561619954921
252561670024892
252561711607885
252561750694886
252571761942105
202231785307685
252571785434313
252561976594925
202232015655849
252561000715653
252561020208865
252561021745698
252561036253574
252571036253574
252561048897083
252561084830817
202231100687785
252561105312235
252561106971740
202231128968198
202231146520148
252561170696087
252571170696087
202231174623829
252561213413554
252571262085396
202231327115844
202231344859684
252561411375131
252571411375131
252561416389496
252561423554704
252571423554704
252561440667840

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
EBF142019-10-29
EMA112016-11-16
ELW92022-01-13
KLE42015-12-09
ELC32013-08-23
EKX32013-08-16
KIF32003-11-03
ELR32000-04-14
EBZ22012-11-27
LQY22011-11-02
KJJ22011-10-28
EKZ22007-10-18
EBG22004-05-13
EKM21985-04-16
EJJ21984-03-16
KMH12005-08-04
MVL12004-06-15
DYH12002-09-18
FRG11999-12-16
EJK11997-10-30
EAT11993-05-27
KGS11991-04-17
EKS11991-03-05
EBI11990-05-15
EIE11990-04-16
EID11986-10-30

PMN#

DuoCem

2016-11-16

COLTENE/WHALEDENT AG

SOLOCEM

2013-01-08

COLTENE/WHALEDENT AG

GUTTAFLOW

2003-11-03

COLTENE/WHALEDENT GMBH & CO. KG

SYNERGY

1998-03-09

COLTENE/WHALEDENT INC.

56 records. Showing 1-40. Next

GUDID#

80 records. Showing 1-40. Next