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Data / Medical devices / Germany / Solventum Germany GmbH

Solventum Germany GmbH: FDA-registered device maker in Kist Bavaria, Germany, 62 510(k) clearances

Solventum Germany GmbH is registered with the FDA (registration 3035693034) in Kist Bavaria, Germany. It lists 25 device types. The FDA files 62 510(k) clearances under its listings, the newest dated November 5, 2019. Registered through 2026. FDA data exported November 2, 2026.

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Get makers like this oneWatch Solventum Germany GmbH
FDA registration number
3035693034
Address
Ringstrasse 14, Kist Bavaria, Germany, 97270
Owner or operator
Solventum US LLC (10091183)
Roles
Exporter to the US
First device listed
December 15, 1977
Registered through
2026
Brand names listed
3M(TM) Nexcare(TM) Gentle Removal Eye Patch, 3M¿ Nexcare¿ Opticlude Orthoptic Eye Patch, Burs, CROWN, OPTICLUDE, OPTICLUDE ORTHOPTIC EYE PATCH, VPS Tray Adhesive

Devices it lists

DeviceProduct codeClassRoleSource
Activator, Ultraviolet, For PolymerizationEBZ2Exporter to the USaccessdata.fda.gov
Agent, Tooth Bonding, ResinKLE2Exporter to the USaccessdata.fda.gov
Alloy, Metal, BaseEJH2Exporter to the USaccessdata.fda.gov
Amalgamator, Dental, Ac-PoweredEFD1Exporter to the USaccessdata.fda.gov
Applicator, ResinKXR1Exporter to the USaccessdata.fda.gov
Bur, DentalEJL1Exporter to the USaccessdata.fda.gov
Cement, DentalEMA2Exporter to the USaccessdata.fda.gov
Coating, Filling Material, ResinEBD2Exporter to the USaccessdata.fda.gov
Cord, RetractionMVLUExporter to the USaccessdata.fda.gov
Crown And Bridge, Temporary, ResinEBG2Exporter to the USaccessdata.fda.gov
Crown, PreformedELZ1Exporter to the USaccessdata.fda.gov
Disk, AbrasiveEHJ1Exporter to the USaccessdata.fda.gov
Drill, Dental, IntraoralDZA1Exporter to the USaccessdata.fda.gov
Instruments, Dental HandDZN1Exporter to the USaccessdata.fda.gov
Liner, Cavity, Calcium HydroxideEJK2Exporter to the USaccessdata.fda.gov
Material, ImpressionELW2Exporter to the USaccessdata.fda.gov
Material, Impression Tray, ResinEBH1Exporter to the USaccessdata.fda.gov
Material, Tooth Shade, ResinEBF2Exporter to the USaccessdata.fda.gov
Post, Root CanalELR1Exporter to the USaccessdata.fda.gov
Powder, PorcelainEIH2Exporter to the USaccessdata.fda.gov
Prophy Powder, Airbrush AccessoryPIP2Exporter to the USaccessdata.fda.gov
Scissors, Collar And CrownEIR1Exporter to the USaccessdata.fda.gov
Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)HOY1Exporter to the USaccessdata.fda.gov
Syringe, Restorative And Impression MaterialEID1Exporter to the USaccessdata.fda.gov
Tray, Impression, PreformedEHY1Exporter to the USaccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
November 5, 2019K192992Suglue 3EMASubstantially Equivalent3M Deutschland GmbHaccessdata.fda.gov
October 31, 2019K192961ADH19KLESubstantially Equivalent3M Deutschland GmbHaccessdata.fda.gov
October 31, 2017K173318Rapid HB, Rapid LB, Rapid MBELWSubstantially Equivalent3M Deutschland GmbHaccessdata.fda.gov
September 1, 2016K161922XP202EIHSubstantially Equivalent3M Deutschland GmbHaccessdata.fda.gov
April 13, 2016K153174Ketac Universal AplicapEMASubstantially Equivalent3M Deutschland GmbHaccessdata.fda.gov
October 24, 2014K140684CLINPRO PROPHY POWDERPIPSubstantially Equivalent3M Deutschland GmbHaccessdata.fda.gov
March 7, 2014K133436FLASH AR; FLASH AR QUICKELWSubstantially Equivalent3M Deutschland GmbHaccessdata.fda.gov
March 6, 2014K133400FLASH BITEELWSubstantially Equivalent3M Espe AGaccessdata.fda.gov
May 30, 2013K131404FLASH AR PENTA / FLASH AR PENTA QUICKELWSubstantially Equivalent3M Deutschland GmbHaccessdata.fda.gov
May 2, 2012K120438FLASH (DIFFERENT MATERIALS)ELWSubstantially Equivalent3M Deutschland GmbHaccessdata.fda.gov
January 13, 2012K120011HEISENBERG EFFECT SHADESEIHSubstantially Equivalent3M Espe AGaccessdata.fda.gov
June 3, 2011K110508SUGLUE-10EMASubstantially Equivalent3M Espe AGaccessdata.fda.gov
May 19, 2011K110302ADHESIVE EXL-759KLESubstantially Equivalent3M Espe AGaccessdata.fda.gov
June 2, 2010K100756MALTAEMASubstantially Equivalent3M Espe AG Dental Productsaccessdata.fda.gov
April 8, 2010K094007UNICEMEMASubstantially Equivalent3M Espe AG Dental Productsaccessdata.fda.gov
February 19, 2010K093721COSP2MVLSubstantially Equivalent3M Espe AG Dental Productsaccessdata.fda.gov
March 26, 2008K080514PECD-01 AND PECD QUICK-01ELWSubstantially Equivalent3M Espe AG Dental Productsaccessdata.fda.gov
January 9, 2008K073296TEMPXN28EBGSubstantially Equivalent3M Espe AG Dental Productsaccessdata.fda.gov
July 25, 2007K071131UNOKLESubstantially Equivalent3M Espe AG Dental Productsaccessdata.fda.gov
October 25, 2006K062292UNICEMEMASubstantially Equivalent3M Espe Dental Productsaccessdata.fda.gov
April 24, 2006K060684ADPER PROMPT, ADPER PROMPT L-POPKLESubstantially Equivalent3M Espe AG Dental Productsaccessdata.fda.gov
July 21, 2005K051797FUTURE WASH/YPSELWSubstantially Equivalent3M Espe AG Dental Productsaccessdata.fda.gov
August 11, 2003K032001POLY Q (GARANT L, PENTA M, PENTA H)ELWSubstantially Equivalent3M Espe AG Dental Productsaccessdata.fda.gov
June 29, 2001K011394LAVA FRAME, LAVA FRAME SHADE, LAVA CERAMEIHSubstantially EquivalentEspe Dental AGaccessdata.fda.gov
May 16, 2001K011154ELIPAR FREELIGHTEBZSubstantially EquivalentEspe Dental AGaccessdata.fda.gov
July 7, 2000K001494MODIFICATION TO PROMPT L-POPKLESubstantially EquivalentEspe Dental AGaccessdata.fda.gov
April 5, 2000K000595DIMENSION PENTA LELWSubstantially EquivalentEspe Dental AGaccessdata.fda.gov
March 30, 2000K000591DIMENSION PENTA H, DIMENSION PENTA H QUICKELWSubstantially EquivalentEspe Dental AGaccessdata.fda.gov
March 30, 2000K000588DIMENSION GARANT L, DIMENSION GARANT L QUICKELWSubstantially EquivalentEspe Dental AGaccessdata.fda.gov
January 28, 2000K994193IMPREGUM PENTA DUOSOFTELWSubstantially EquivalentEspe Dental AGaccessdata.fda.gov
January 27, 2000K994190IMPREGUM GARANT L DUOSOFTELWSubstantially EquivalentEspe Dental AGaccessdata.fda.gov
January 3, 2000K994251KETAC-MOLAR QUICKEBFSubstantially EquivalentEspe Dental AGaccessdata.fda.gov
September 8, 1999K992897IMPREGUM PENTAELWSubstantially EquivalentEspe Dental AGaccessdata.fda.gov
September 8, 1999K992895IMPREGUM FELWSubstantially EquivalentEspe Dental AGaccessdata.fda.gov
July 26, 1999K991913PENTAMIX 2EFDSubstantially EquivalentEspe Dental AGaccessdata.fda.gov
June 18, 1999K991008DIMENSION BITEELWSubstantially EquivalentEspe Dental AGaccessdata.fda.gov
January 8, 1999K984248PROCEMEMASubstantially EquivalentEspe Dental AGaccessdata.fda.gov
January 29, 1998K974231POSITION PENTA, POSITION PENTA QUICKELWSubstantially EquivalentEspe GmbH & Co. Kg.accessdata.fda.gov
November 17, 1997K973262KETAC-FIL APLICAP PLUSEMASubstantially EquivalentEspe GmbH & Co. Kg.accessdata.fda.gov
August 29, 1997K9723553M AURORA SYSTEMEBZSubstantially Equivalent3M Companyaccessdata.fda.gov
November 27, 1996K963735COJET SYSTEMEBFSubstantially EquivalentEspe GmbH & Co. Kg.accessdata.fda.gov
May 16, 1996K960954KETAC-MOLAR APLICAPEMASubstantially EquivalentEspe GmbH & Co. Kg.accessdata.fda.gov
March 15, 1996K960547DIMENSION PENTA/DIMENSION GARANT L/POLYVINYL SILOXANE ADHESIVEELWSubstantially EquivalentEspe GmbH & Co. Kg.accessdata.fda.gov
August 18, 1995K953374PERMADYNE GARANT 2:1ELWSubstantially EquivalentEspe GmbH & Co. Kg.accessdata.fda.gov
July 19, 1995K953027PERMADYNE PENTA (HIGH & LOW VISCOSITY)ELWSubstantially EquivalentEspe GmbH & Co. Kg.accessdata.fda.gov
June 18, 1993K925027PHOTAC-FIL APLICAPEMASubstantially EquivalentEspe GmbH (Us)accessdata.fda.gov
November 25, 1992K9248123M CURING LIGHT XL 3000EBZSubstantially Equivalent3M Companyaccessdata.fda.gov
December 16, 1991K913857ROCATEC(R) -PLUSEJHSubstantially EquivalentEspe GmbH (Us)accessdata.fda.gov
December 4, 1991K913965ESPE(R) -SILKLESubstantially EquivalentEspe GmbH (Us)accessdata.fda.gov
March 28, 1990K900436PROTEMP IIEBGSubstantially EquivalentEspe GmbH (Us)accessdata.fda.gov
March 27, 1990K897188KETAC-CEM MAXICAPEMASubstantially EquivalentEspe GmbH (Us)accessdata.fda.gov
January 19, 1989K884752KETAC-GLAZEKLESubstantially EquivalentEspe GmbH (Us)accessdata.fda.gov
April 12, 1988K874788KETAC-BOND APLICAPEMASubstantially EquivalentEspe GmbH (Us)accessdata.fda.gov
March 9, 1988K875228PERMADYNE ADHESIVEEBHSubstantially EquivalentEspe GmbH (Us)accessdata.fda.gov
March 9, 1988K872984KETAC-CONDITIONEREMASubstantially EquivalentEspe GmbH (Us)accessdata.fda.gov
March 1, 1988K875133CAVIT-WEBGSubstantially EquivalentEspe GmbH (Us)accessdata.fda.gov
August 19, 1985K844845ESPE KETAC-BONDEBDSubstantially EquivalentEspe GmbH (Us)accessdata.fda.gov
March 25, 1985K844846ESPE KETAC-CEM RADIOPAQUEEMASubstantially EquivalentEspe GmbH (Us)accessdata.fda.gov
December 6, 1984K843566KETAC-SILVEREMASubstantially EquivalentEspe GmbH (Us)accessdata.fda.gov
February 23, 1981K810266ETCHING GELEJKSubstantially EquivalentEspe-Premier Sales Co.accessdata.fda.gov
February 5, 1980K800031PERMADYNE POLYETHER RUBBER IMPRESSIONELWSubstantially EquivalentEspe Dental Productsaccessdata.fda.gov
August 16, 1977K771451SCUTABONDEMASubstantially EquivalentPremier Dental Products Co.accessdata.fda.gov

Compare with other makers

Updated November 5, 2019. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.