FDA.reportPublic FDA data

Solventum Germany GmbH

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
96113853002806930Solventum Germany GmbH1N2026-01-01ESPE PLATZ SEEFELD Bavaria DE 82229

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
00197998018930Solventum™ - Solventum™ Penta™ VPS Impression Material Heavy-Bodied ConsistencyHydrophilic, 36716, 600 mL base, 120 mL catalyst, 2/PAC+1(800)634-2249regulatoryrequests@solventum.com
00197998018947Solventum™ - Solventum™ Paradigm™ Penta™ Fast Set VPS Impression MaterialHydrophilic, 36717, 600 mL base, 120 mL catalyst, 2/PAC+1(800)634-2249regulatoryrequests@solventum.com
00197998022579Solventum™ - Solventum™ Rotating Capsule Mixing Device, 76310, 1 EA+1(800)634-2249regulatoryrequests@solventum.com
00197998118654Solventum™ Promogran Prisma™ - Solventum™ Promogran Prisma™ Collagen Matrix with ORC and Silver, MA032, 3/8 in x 3/8 in x 12 5/8 in, 6/CAR+1(800)228-3957regulatoryrequests@solventum.com
00197998175190Solventum™ Promogran Prisma™ - Solventum™ Promogran Prisma™ Collagen Matrix with ORC and Silver, PS2123, 19.1 in2 (123 cm2), Hexagon, 10/CAR, 4 CAR/CS, 40/CS+1(800)228-3957regulatoryrequests@solventum.com
00197998291128Solventum™ Promogran Prisma™ - Solventum™ Promogran Prisma™ Collagen Matrix with ORC and Silver, MA123, Hexagon, 19.1 sq in (123 sq cm), 10/CAR, 4 CAR/CS, 40/CS+1(800)228-3957regulatoryrequests@solventum.com
00197998291166Solventum™ Promogran Prisma™ - Solventum™ Promogran Prisma™ Collagen Matrix with ORC and Silver, MA028, Hexagon, 4.34 sq in (28 sq cm), 10/CAR, 4 CAR/CS, 40/CS+1(800)228-3957regulatoryrequests@solventum.com
00197998291203Solventum™ Promogran Prisma™ - Solventum™ Promogran Prisma™ Collagen Matrix with ORC and Silver, PS2028, Hexagon, 24.34 sq in (28 sq cm), 10/CAR, 4 CAR/CS, 40/CS+1(800)228-3957regulatoryrequests@solventum.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3427451610937939K994251KETAC-MOLAR QUICKEBF2000-01-03
3427452002264140K994193IMPREGUM PENTA DUOSOFTELW2000-01-28
3427452070830022K994192IMPREGUM PENTA M MONOSOFTELW2000-01-28
3427452068926481K994190IMPREGUM GARANT L DUOSOFTELW2000-01-27
3427451089380537K992897IMPREGUM PENTAELW1999-09-08
3427451870195965K992895IMPREGUM FELW1999-09-08
3427451265492118K991913PENTAMIX 2EFD1999-07-26
3427451310677233K991008DIMENSION BITEELW1999-06-18
3427451094645196K984248PROCEMEMA1999-01-08
3427452065564706K974231POSITION PENTA, POSITION PENTA QUICKELW1998-01-29
3427451874216126K973262KETAC-FIL APLICAP PLUSEMA1997-11-17
3427451995115998K9723553M AURORA SYSTEMEBZ1997-08-29
3427451031236138K963735COJET SYSTEMEBF1996-11-27
3427451654296724K960954KETAC-MOLAR APLICAPEMA1996-05-16
3427452034278321K960547DIMENSION PENTA/DIMENSION GARANT L/POLYVINYL SILOXANE ADHESIVEELW1996-03-15
3427451422948895K953374PERMADYNE GARANT 2:1ELW1995-08-18
3427452040672590K953027PERMADYNE PENTA (HIGH & LOW VISCOSITY)ELW1995-07-19
3427452048358759K925027PHOTAC-FIL APLICAPEMA1993-06-18
3427451796351787K9248123M CURING LIGHT XL 3000EBZ1992-11-25
3427451538246906K913965ESPE(R) -SILKLE1991-12-04
3427451497626627K913857ROCATEC(R) -PLUSEJH1991-12-16
3427451925721089K900436PROTEMP IIEBG1990-03-28
3427451308315153K897188KETAC-CEM MAXICAPEMA1990-03-27
3427451842124831K884752KETAC-GLAZEKLE1989-01-19
3427451606468147K875228PERMADYNE ADHESIVEEBH1988-03-09
3427451948578613K875133CAVIT-WEBG1988-03-01
3427451582889669K874788KETAC-BOND APLICAPEMA1988-04-12
3427451358788777K872984KETAC-CONDITIONEREMA1988-03-09
3427451589365467K844846ESPE KETAC-CEM RADIOPAQUEEMA1985-03-25
3427451847709791K844845ESPE KETAC-BONDEBD1985-08-19
3427451317538910K843566KETAC-SILVEREMA1984-12-06
3427451841580344K810266ETCHING GELEJK1981-02-23
3427451183123639K800031PERMADYNE POLYETHER RUBBER IMPRESSIONELW1980-02-05
3427451041824387K771451SCUTABONDEMA1977-08-16
3427451833058374K2313383M™ Clinpro™ Clear 2.1% Sodium Fluoride TreatmentLBH2023-05-10
3427451515505247K220257PermadyneELW2022-02-01
3427451743911524K192992Suglue 3EMA2019-11-05
3427451298327222K192961ADH19KLE2019-10-31
3427451401760449K173318Rapid HB, Rapid LB, Rapid MBELW2017-10-31
3427451384182823K161922XP202EIH2016-09-01
3427451775763775K153174Ketac Universal AplicapEMA2016-04-13
3427451860785150K140684CLINPRO PROPHY POWDERPIP2014-10-24
3427451144358399K133436FLASH AR; FLASH AR QUICKELW2014-03-07
3427451448582233K133400FLASH BITEELW2014-03-06
3427451938204725K131404FLASH AR PENTA / FLASH AR PENTA QUICKELW2013-05-30
3427452047605822K120438FLASH (DIFFERENT MATERIALS)ELW2012-05-02
3427451252244715K120011HEISENBERG EFFECT SHADESEIH2012-01-13
3427451558090785K110508SUGLUE-10EMA2011-06-03
3427451055261942K110302ADHESIVE EXL-759KLE2011-05-19
3427451537328435K100756MALTAEMA2010-06-02
3427451811171062K094007UNICEMEMA2010-04-08
3427451038588397K093721COSP2MVL2010-02-19
3427451611886844K080514PECD-01 AND PECD QUICK-01ELW2008-03-26
3427451304172697K073296TEMPXN28EBG2008-01-09
3427451567314267K071131UNOKLE2007-07-25
3427451826482576K062292UNICEMEMA2006-10-25
3427451223146632K060684ADPER PROMPT, ADPER PROMPT L-POPKLE2006-04-24
3427451090465275K051797FUTURE WASH/YPSELW2005-07-21
3427451054839873K032001POLY Q (GARANT L, PENTA M, PENTA H)ELW2003-08-11
3427451932955471K011394LAVA FRAME, LAVA FRAME SHADE, LAVA CERAMEIH2001-06-29
3427451616152220K011154ELIPAR FREELIGHTEBZ2001-05-16
3427451323822647K001494MODIFICATION TO PROMPT L-POPKLE2000-07-07
3427452020046368K000595DIMENSION PENTA LELW2000-04-05
3427451535105993K000591DIMENSION PENTA H, DIMENSION PENTA H QUICKELW2000-03-30
3427451260960081K000588DIMENSION GARANT L, DIMENSION GARANT L QUICKELW2000-03-30
3427451006836646
3427451020708636
3427451095256412
3427451101399267
3427451167674181
3427451226261175
3427451286210314
3427451339903925
3427451422424293
3427451532695590
3427451744013356
3427451865223176
3427452014949680
3427452066419443

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
ELW232022-02-01
EMA162019-11-05
KLE72019-10-31
EIH32016-09-01
EBG32008-01-09
EBZ32001-05-16
EBF22000-01-03
LBH12023-05-10
PIP12014-10-24
MVL12010-02-19
EFD11999-07-26
EJH11991-12-16
EBH11988-03-09
EBD11985-08-19
EJK11981-02-23

GUDID#