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Data / Medical devices / United States / Solventum US LLC

Solventum US LLC: FDA-registered device maker in Irvine, CA, United States, 39 510(k) clearances

Solventum US LLC is registered with the FDA (registration 3032163716) in Irvine, CA, United States. It lists 25 device types. The FDA files 39 510(k) clearances under its listings, the newest dated December 22, 2023. Registered through 2026. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers like this oneWatch Solventum US LLC
FDA registration number
3032163716
Address
2111 McGaw Avenue, Irvine, CA, United States, 92614
Owner or operator
Solventum US LLC (10091183)
Roles
Contract manufacturer, Manufacturer, Repackager or relabeler
First device listed
August 31, 1978
Registered through
2026
Brand names listed
Burs, CROWN, Transbond LR, Transbond Supreme Adhesive,, Transbond Supreme LV Adhesive,, Transbond Supreme LV Light Cure Adhesive, Transbond Supreme Low Viscosity Adh, Transbond XT and more

Devices it lists

DeviceProduct codeClassRoleSource
Accessories, Implant, Dental, EndosseousNDP1Repackager or relabeleraccessdata.fda.gov
Accessories, Retractor, DentalEIF1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Activator, Ultraviolet, For PolymerizationEBZ2Repackager or relabeleraccessdata.fda.gov
Adhesive, Bracket And Tooth Conditioner, ResinDYH2Contract manufacturer, Manufactureraccessdata.fda.gov
Agent, Tooth Bonding, ResinKLE2Manufactureraccessdata.fda.gov
Applicator, ResinKXR1Repackager or relabeleraccessdata.fda.gov
Bracket, Ceramic, OrthodonticNJM2Contract manufactureraccessdata.fda.gov
Bracket, Metal, OrthodonticEJF1Contract manufactureraccessdata.fda.gov
Bracket, Plastic, OrthodonticDYW2Contract manufactureraccessdata.fda.gov
Bur, DentalEJL1Repackager or relabeleraccessdata.fda.gov
Cement, DentalEMA2Manufactureraccessdata.fda.gov
Crown And Bridge, Temporary, ResinEBG2Manufactureraccessdata.fda.gov
Crown, PreformedELZ1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Disk, AbrasiveEHJ1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Implant, Endosseous, Root-FormDZE2Manufactureraccessdata.fda.gov
Instruments, Dental HandDZN1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Liner, Cavity, Calcium HydroxideEJK2Manufacturer, Repackager or relabeleraccessdata.fda.gov
Material, ImpressionELW2Manufactureraccessdata.fda.gov
Material, Tooth Shade, ResinEBF2Contract manufacturer, Manufactureraccessdata.fda.gov
Powder, PorcelainEIH2Manufactureraccessdata.fda.gov
Sealant, Pit And Fissure, And ConditionerEBC2Manufactureraccessdata.fda.gov
Spring, OrthodonticECO1Repackager or relabeleraccessdata.fda.gov
Tube Impression And MatrixKCQ1Manufactureraccessdata.fda.gov
Varnish, CavityLBH2Manufacturer, Repackager or relabeleraccessdata.fda.gov
Wheel, Polishing AgentEJQ1Repackager or relabeleraccessdata.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
December 22, 2023K2340433M™ Transbond™ Orthodontic AdhesiveDYHSubstantially Equivalent3M Unitek Orthodontic Productsaccessdata.fda.gov
May 10, 2023K2313383M™ Clinpro™ Clear 2.1% Sodium Fluoride TreatmentLBHSubstantially Equivalent3M Espe Dental Productsaccessdata.fda.gov
February 6, 2023K2302703M™ VitCal Liner/BaseEJKSubstantially Equivalent3M Espe Dental Productsaccessdata.fda.gov
June 13, 2022K2216953M Filtek Supreme Flowable RestorativeEBFSubstantially Equivalent3M Company Espe Dental Productsaccessdata.fda.gov
January 2, 2019K1834763M Filtek Universal RestorativeEBFSubstantially Equivalent3M Espe Dental Productsaccessdata.fda.gov
November 28, 2016K163207Filtek One Bulk Fill RestorativeEBFSubstantially Equivalent3M Companyaccessdata.fda.gov
May 8, 2014K141081FILTEK BULK FILL POSTERIOR RESTROATIVEEBFSubstantially Equivalent3M Espe Dental Productsaccessdata.fda.gov
March 19, 2012K120453FILTEK BULK FILL FLOWABLE RESTORATIVEEBFSubstantially Equivalent3M Espe Dental Productsaccessdata.fda.gov
May 5, 2011K111185RELYX LUTING PLUS AUTOMIXEMASubstantially Equivalent3M Espe Dental Productsaccessdata.fda.gov
January 21, 2011K110131LAVA ULTIMATE CAD/CAM RESTORATIVE FOR CEREC / E4D, LAVA ULTIMATE IMPLANT CROWN RESTORATIVEEBFSubstantially Equivalent3M Espe Dental Productsaccessdata.fda.gov
May 12, 2010K100235FILTEK SUPREME ULTRA FLOWABLE RESTORATIVEEBFSubstantially Equivalent3M Companyaccessdata.fda.gov
March 10, 2010K092141VANISH VARNISH, 5% SODIUM FLUORIDE WHITE VARNISHLBHSubstantially Equivalent3M Espe Dental Productsaccessdata.fda.gov
December 17, 2008K083610FILTEK SUPREME ULTRA UNIVERSAL RESTORATIVEEBFSubstantially Equivalent3M Companyaccessdata.fda.gov
January 17, 2008K073395GILB-2, GLASS IONOMER PROTECTIVE COATINGEMASubstantially Equivalent3M Espe Dental Productsaccessdata.fda.gov
September 27, 2005K052235LCREMASubstantially Equivalent3M Companyaccessdata.fda.gov
September 15, 2004K042289MDI ORTHODZESubstantially EquivalentImtec Corp.accessdata.fda.gov
August 2, 2002K022476RELYX RMGIPEMASubstantially Equivalent3M Companyaccessdata.fda.gov
June 14, 2001K011200GILB, MODEL 8010EMASubstantially Equivalent3M Companyaccessdata.fda.gov
April 13, 2001K0107813M ESPE HAUREBFSubstantially Equivalent3M Companyaccessdata.fda.gov
September 28, 2000K0024523M RELY X VENEER CEMENT TRY-IN PASTEREMASubstantially Equivalent3M Companyaccessdata.fda.gov
October 8, 1999K9923263M CLINPRO SEALANTEBCSubstantially Equivalent3M Companyaccessdata.fda.gov
August 9, 1999K9919613M LVR SYSTEMEBFSubstantially Equivalent3M Companyaccessdata.fda.gov
August 9, 1998K9816473M DENT II SYSTEMEBFSubstantially Equivalent3M Companyaccessdata.fda.gov
December 17, 1997K9739613M DENT SYSTEM II PLUSEMASubstantially Equivalent3M Companyaccessdata.fda.gov
August 29, 1997K9723553M AURORA SYSTEMEBZSubstantially Equivalent3M Companyaccessdata.fda.gov
October 31, 1996K9637663M PROPLUS SYSTEMELWSubstantially Equivalent3M Companyaccessdata.fda.gov
August 12, 1996K9627853M DENT SYSTEMKLESubstantially Equivalent3M Companyaccessdata.fda.gov
January 5, 1994K9331393M VITREMER LUTING CEMENTEMASubstantially Equivalent3M Companyaccessdata.fda.gov
December 23, 1992K9250323M VITREMER TRI-CURE GLASS IONOMER SYSTEMEMASubstantially Equivalent3M Companyaccessdata.fda.gov
November 25, 1992K9248123M CURING LIGHT XL 3000EBZSubstantially Equivalent3M Companyaccessdata.fda.gov
March 20, 1992K9204253M BRAND RESTORATIVE Z100EBFSubstantially Equivalent3M Companyaccessdata.fda.gov
March 20, 1992K920424SCOTCHBOND BRAND MULTI-PURPOSE ADHESIVE SYSTEMKLESubstantially Equivalent3M Companyaccessdata.fda.gov
May 29, 1991K911271ADHESIVE PRECOATED BRACKETSDYHSubstantially EquivalentUnitek Corp.accessdata.fda.gov
August 11, 1988K882690IMPRINT VINYL POLYSILOXANE IMPRESSION MATERIALELWSubstantially Equivalent3M Companyaccessdata.fda.gov
November 14, 1985K853698SCOTCHPRIME CERAMIC PRIMEREIHSubstantially Equivalent3M Companyaccessdata.fda.gov
January 7, 1985K844211CONCISE LIGHT CURED WHITE SEALANTEBCSubstantially Equivalent3M Companyaccessdata.fda.gov
January 12, 1982K813180SCOTCHBOND DENTAL ADHESIVEKLESubstantially Equivalent3M Companyaccessdata.fda.gov
February 23, 1981K810266ETCHING GELEJKSubstantially EquivalentEspe-Premier Sales Co.accessdata.fda.gov
March 18, 1980K800485VINYL POLYSILOXANE IMPRESSION MATERIALELWSubstantially Equivalent3M Companyaccessdata.fda.gov

Compare with other makers

Updated December 22, 2023. 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.