Manufacturer registered with FDA

Solventum US LLC

San Antonio, TX, United States. Lists 60 dental device types with FDA across 8 registered establishments.

FDA owner/operator10091183Contract manufacturerManufacturer for exportForeign exporterManufacturer

Device types listed: 60
Brands and models: 45
510(k) clearances: 0as applicant
Markets registered in: 152,342 registrations outside the US
Establishments: 8Germany, Poland, United States

Registered in 15 markets

Where regulators' registries name Solventum US LLC as the manufacturer or the registration holder of a device.

RegisteredHome: United StatesOne marker per market

Market	Regulator	Named as	Name on the registry	Registrations	Issued	Records
United States	FDA	Manufacturer	Solventum US LLC	60 device types	—	Below
European Union	EUDAMED	Manufacturer	Solventum Orthodontics CorporationSolventum Germany GmbH · Solventum US LLC	1,486	—	Pure Global AI
Canada	Health Canada	Registration holder	SOLVENTUM ORTHODONTICS CORPORATIONSOLVENTUM US LLC · SOLVENTUM GERMANY GMBH	330	1998–2026	Pure Global AI
Colombia	INVIMA	Manufacturer	SOLVENTUM US LLCSOLVENTUM GERMANY GMBH · SOLVENTUM ORTHODONTICS CORPORATION · +1	168	—	Pure Global AI
Australia	TGA	Manufacturer	Solventum Germany GmbHSolventum US LLC · Solventum Orthodontics Corporation	77	2024–2026	Pure Global AI
Serbia	ALIMS	Manufacturer	Solventum Germany GmbHSolventum US LLC	65	2025–2026	Pure Global AI
United Kingdom	MHRA	Manufacturer	Solventum Germany GmbHSolventum US LLC · Solventum Orthodontics Corporation	57	—	Pure Global AI
Brazil	ANVISA	Manufacturer	SOLVENTUM ORTHODONTICS CORPORATIONSOLVENTUM US LLC · SOLVENTUM GERMANY GMBH	32	2016–2026	Pure Global AI
Costa Rica	Ministerio de Salud	Manufacturer	Solventum Orthodontics CorporationSolventum Germany GmbH · Solventum US LLC	30	—	Pure Global AI
Israel	AMAR	Manufacturer	Solventum Germany GmbHSolventum US LLC · Solventum Orthodontics Corporation	25	—	Pure Global AI
Hong Kong	MDD	Manufacturer	Solventum Germany GmbHSolventum Orthodontics Corporation · SOLVENTUM US LLC · +1	19	2025–2026	Pure Global AI
China	NMPA	Registration holder	舒万诺美国有限公司Solventum US LLCSolventum Orthodontics Corporation (舒万诺齿科解决方案正畸产品公司) · Solventum Germany GmbH（舒万诺德国有限公司) · +2	16	—	Pure Global AI
South Korea	MFDS	Manufacturer	Solventum Orthodontics CorporationSolventum Germany GmbH · Solventum US LLC · +1	16	2001–2019	Pure Global AI
Peru	DIGEMID	Manufacturer	SOLVENTUM GERMANY GMBHSOLVENTUM US LLC	12	2026–2026	Pure Global AI
Taiwan	TFDA	Manufacturer	Solventum Germany GmbHSolventum US LLC · Solventum Poland Manufacturing Sp z o.o.	9	2005–2026	Pure Global AI

Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026

Devices listed with FDA

What Solventum US LLC currently lists, by FDA device type, with the brand and model names on the listing.

Device type	Category	Role	Brands and models	Listed since
Dental CementEMA · Class 2	Dental cements	Maker	—	2005
Impression MaterialELW · Class 2	Impression materials	Maker	Impregum Penta Soft MBVPS Tray Adhesive	1977
Resin Tooth Shade MaterialEBF · Class 2	Dental composites	Maker	—	2007
Resin Tooth Bonding AgentKLE · Class 2	Bonding agents	Maker	—	2007
Resin Bracket and Tooth Conditioner AdhesiveDYH · Class 2	—	Maker	Transbond LRTransbond Supreme Adhesive,Transbond Supreme Low Viscosity AdhTransbond Supreme LV Adhesive,Transbond Supreme LV Light Cure AdhesiveTransbond XTUnitek Multi-Cure Glass Ionomer Orthodontic Band Cement	2007
Pit and Fissure Sealant and ConditionerEBC · Class 2	Sealants & varnishes	Maker	—	2007
Cavity VarnishLBH · Class 2	Sealants & varnishes	Maker	—	2008
Resin Temporary Crown and BridgeEBG · Class 2	Temporary crown & bridge materials	Maker	—	2008
Calcium Hydroxide Cavity LinerEJK · Class 2	—	Maker	—	2008
Ultraviolet Activator for PolymerizationEBZ · Class 2	Curing lights	Maker	—	2007
Porcelain PowderEIH · Class 2	Dental ceramics & zirconia	Maker	—	2008
Dental Hand InstrumentsDZN · Class 1	Dental hand instruments	Maker	—	2001
Preformed Impression TrayEHY · Class 1	Impression trays	Maker	—	2000
Orthodontic Metal BracketEJF · Class 1	Orthodontic brackets	Maker	—	1992
Resin ApplicatorKXR · Class 1	—	Maker	—	2001
Abrasive DiskEHJ · Class 1	Polishing & prophylaxis	Maker	—	2001
Restorative and Impression Material SyringeEID · Class 1	Dental hand instruments	Maker	—	1978
Preformed CrownELZ · Class 1	—	Maker	CROWN	2001
Orthodontic Ceramic BracketNJM · Class 2	Orthodontic brackets	Maker	—	2011
Resin Impression Tray MaterialEBH · Class 1	Impression trays	Maker	Incognito Indirect Bonding Tray	1999
Ac-Powered Dental AmalgamatorEFD · Class 1	—	Maker	—	2008
Collar and Crown ScissorsEIR · Class 1	Dental hand instruments	Maker	—	2025
Dental BurEJL · Class 1	Dental burs & diamonds	Maker	Burs	2003
Tube Impression and MatrixKCQ · Class 1	—	Maker	—	2025
Orthodontic Plastic BracketDYW · Class 2	Orthodontic brackets	Maker	Clarity	2007
Polishing Agent WheelEJQ · Class 1	Polishing & prophylaxis	Maker	—	1992
Root Canal PostELR · Class 1	Root canal filling materials	Maker	—	2006
Endosseous Dental Implant AccessoriesNDP · Class 1	Implant instruments & surgical kits	Maker	—	2011
Sequential AlignerNXC · Class 2	Clear aligners	Maker	—	2020
Intraoral Dental DrillDZA · Class 1	Surgical drills & motors	Maker	—	2006
Orthodontic WireDZC · Class 1	Orthodontic wires & bands	Maker	Hi-TIncognitoUnitek	1992
Orthodontic TubeDZD · Class 1	Orthodontic wires & bands	Maker	—	1992
Root-Form Endosseous ImplantDZE · Class 2	Dental implants	Maker	—	2010
Resin Filling Material CoatingEBD · Class 2	—	Maker	—	2008
Orthodontic Preformed BandECM · Class 1	Orthodontic wires & bands	Maker	Unitek (TM) BandsVictory Series (TM) Bands	1992
Orthodontic SpringECO · Class 1	Orthodontic wires & bands	Maker	—	2024
Dental Contra- and Right-Angle Attachment HandpieceEGS · Class 1	Dental handpieces	Maker	—	2007
Dental Retractor AccessoriesEIF · Class 1	Dental hand instruments	Maker	—	1978
Base Metal AlloyEJH · Class 2	Dental alloys	Maker	—	2008
Operative PliersEJY · Class 1	Dental hand instruments	Maker	—	2001
Dental FlossJES · Class 1	Floss & interdental cleaners	Maker	—	2008
Airbrush Accessory Prophy PowderPIP · Class 2	—	Maker	—	2014
Orthodontic Screw Expansion RetainerDYJ · Class 1	Retainers, expanders & headgear	Lister	Orthodontic Expansion Screws3M Unitek	1992
Orthodontic Material BandDYO · Class 1	Orthodontic wires & bands	Maker	—	1992
Orthodontic Space Preformed MaintainerDYT · Class 1	Retainers, expanders & headgear	Maker	—	2018
Orthodontic Extraoral HeadgearDZB · Class 2	Retainers, expanders & headgear	Maker	Friction-Stop Adjustage FacebowLevel Anchorage FacebowNWO HeadgearNWO Snap-waySeries 5 FacebowTraction Release Headgear	2007
Mouth MirrorEAX · Class 1	Dental hand instruments	Maker	Mouth MirrorUnitek	1992
Orthodontic Elastic BandECI · Class 1	Orthodontic wires & bands	Maker	Action Line Thread and TubingAlastiK Ligatures, Chain, Separators, ModulesLingual Rotation WedgeOrthodontic Elastics	1992
Orthodontic Wire ClampECN · Class 1	—	Maker	Gurin AuxiliariesUnitek Crimpable Hooks and Posts	2011
Orthodontic Ligature Tucking InstrumentECP · Class 1	Dental hand instruments	Maker	Unitek	1992
Orthodontic Bracket AlignerECQ · Class 1	Dental hand instruments	Maker	Boone Bracket Positioning Gauge	2013
Orthodontic Band SetterECR · Class 1	Dental hand instruments	Maker	Molar Band Seater	1992
Orthodontic Band PusherECS · Class 1	Dental hand instruments	Maker	Lightweight Band Seater and Pusher	1992
Dental Dressing ForcepsEFL · Class 1	Dental hand instruments	Maker	Unitek	2002
Intraoral Dental WaxEGD · Class 1	—	Maker	Orthodontic Wax	1999
Dental Instrument Depth GaugeEIL · Class 1	Dental hand instruments	Maker	Bracket Positioning Gauges	1992
Alloy Other Noble MetalEJS · Class 2	Dental alloys	Maker	SILVER SOLDER	1992
Periodontic ScalerEMN · Class 1	Dental hand instruments	Maker	Sickle-Style Cement Remover	2016
Orthodontic PlierJEX · Class 1	Dental hand instruments	Maker	PrestigeUnitek	1992
Composite Resin WarmerQGO · Class 1	—	Maker	—	2025

Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026

Also lists devices cleared under other names

Solventum US LLC lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.

Original applicants: 3M Company (27), Espe Dental AG (15), Espe GmbH (Us) (13), 3M Espe Dental Products (10), 3M Deutschland GmbH (10), 3M Espe AG Dental Products (8), Espe GmbH & Co. Kg. (7), 3M Unitek Corporation (5).

Decided	510(k)	Device	Applicant	Device type
22 Dec 2023	K234043	3M Transbond Orthodontic Adhesive	3M Unitek Orthodontic Products	DYH Resin Bracket and Tooth Conditioner Adhesive
29 Sep 2023	K233257	3M ClarityAligners with Quick Attachments	3M Company, Unitek Orthodontic Products	NXC Sequential Aligner
22 May 2023	K231464	3M Clarity Aligners (3M Clarity Aligners-Force, 3M Clarity Aligners-Flex)	3M Company, Unitek Orthodontic Products	NXC Sequential Aligner
10 May 2023	K231338	3M Clinpro Clear 2.1% Sodium Fluoride Treatment	3M Espe Dental Products	LBH Cavity Varnish
6 Feb 2023	K230270	3M VitCal Liner/Base	3M Espe Dental Products	EJK Calcium Hydroxide Cavity Liner
13 Jun 2022	K221695	3M Filtek Supreme Flowable Restorative	3M Company Espe Dental Products	EBF Resin Tooth Shade Material
1 Feb 2022	K220257	Permadyne	3M Deutschland GmbH	ELW Impression Material
5 Nov 2019	K192992	Suglue 3	3M Deutschland GmbH	EMA Dental Cement
31 Oct 2019	K192961	ADH19	3M Deutschland GmbH	KLE Resin Tooth Bonding Agent
5 Sep 2019	K192119	3M Clarity Aligners	3M Company	NXC Sequential Aligner
2 Jan 2019	K183476	3M Filtek Universal Restorative	3M Espe Dental Products	EBF Resin Tooth Shade Material
16 Mar 2018	K180404	3M Clarity Ultra Self-Ligating Brackets and Adhesive Coated Appliance System	3M Healthcare	NJM Orthodontic Ceramic Bracket
31 Oct 2017	K173318	Rapid HB, Rapid LB, Rapid MB	3M Deutschland GmbH	ELW Impression Material
28 Nov 2016	K163207	Filtek One Bulk Fill Restorative	3M Company	EBF Resin Tooth Shade Material
1 Sep 2016	K161922	XP202	3M Deutschland GmbH	EIH Porcelain Powder
13 Apr 2016	K153174	Ketac Universal Aplicap	3M Deutschland GmbH	EMA Dental Cement
24 Oct 2014	K140684	CLINPRO PROPHY POWDER	3M Deutschland GmbH	PIP Airbrush Accessory Prophy Powder
8 May 2014	K141081	FILTEK BULK FILL POSTERIOR RESTROATIVE	3M Espe Dental Products	EBF Resin Tooth Shade Material
7 Mar 2014	K133436	FLASH AR; FLASH AR QUICK	3M Deutschland GmbH	ELW Impression Material
6 Mar 2014	K133400	FLASH BITE	3M Espe AG	ELW Impression Material
1 Nov 2013	K132109	ENAMELAST	Ultradent Products Inc. / Oratech, LLC	LBH Cavity Varnish
30 May 2013	K131404	FLASH AR PENTA / FLASH AR PENTA QUICK	3M Deutschland GmbH	ELW Impression Material
2 May 2012	K120438	FLASH (DIFFERENT MATERIALS)	3M Deutschland GmbH	ELW Impression Material
19 Mar 2012	K120453	FILTEK BULK FILL FLOWABLE RESTORATIVE	3M Espe Dental Products	EBF Resin Tooth Shade Material
2 Feb 2012	K113197	APC FLASH-FREE ADHESIVE	3M Unitek Corporation	DYH Resin Bracket and Tooth Conditioner Adhesive
13 Jan 2012	K120011	HEISENBERG EFFECT SHADES	3M Espe AG	EIH Porcelain Powder
3 Jun 2011	K110508	SUGLUE-10	3M Espe AG	EMA Dental Cement
19 May 2011	K110302	ADHESIVE EXL-759	3M Espe AG	KLE Resin Tooth Bonding Agent
5 May 2011	K111185	RELYX LUTING PLUS AUTOMIX	3M Espe Dental Products	EMA Dental Cement
17 Feb 2011	K102803	CLARITY ADVANCED CERAMIC BRACKETS	3M Unitek Corporation	NJM Orthodontic Ceramic Bracket
21 Jan 2011	K110131	LAVA ULTIMATE CAD/CAM RESTORATIVE FOR CEREC / E4D, LAVA ULTIMATE IMPLANT CROWN RESTORATIVE	3M Espe Dental Products	EBF Resin Tooth Shade Material
2 Jun 2010	K100756	MALTA	3M Espe AG Dental Products	EMA Dental Cement
12 May 2010	K100235	FILTEK SUPREME ULTRA FLOWABLE RESTORATIVE	3M Company	EBF Resin Tooth Shade Material
8 Apr 2010	K094007	UNICEM	3M Espe AG Dental Products	EMA Dental Cement
10 Mar 2010	K092141	VANISH VARNISH, 5% SODIUM FLUORIDE WHITE VARNISH	3M Espe Dental Products	LBH Cavity Varnish
17 Dec 2008	K083610	FILTEK SUPREME ULTRA UNIVERSAL RESTORATIVE	3M Company	EBF Resin Tooth Shade Material
26 Mar 2008	K080514	PECD-01 AND PECD QUICK-01	3M Espe AG Dental Products	ELW Impression Material
15 Feb 2008	K073697	TRANSBOND SUPREME ADHESIVE	3M Unitek Corporation	DYH Resin Bracket and Tooth Conditioner Adhesive
17 Jan 2008	K073395	GILB-2, GLASS IONOMER PROTECTIVE COATING	3M Espe Dental Products	EMA Dental Cement
9 Jan 2008	K073296	TEMPXN28	3M Espe AG Dental Products	EBG Resin Temporary Crown and Bridge
25 Jul 2007	K071131	UNO	3M Espe AG Dental Products	KLE Resin Tooth Bonding Agent
25 Oct 2006	K062292	UNICEM	3M Espe Dental Products	EMA Dental Cement
24 Apr 2006	K060684	ADPER PROMPT, ADPER PROMPT L-POP	3M Espe AG Dental Products	KLE Resin Tooth Bonding Agent
27 Sep 2005	K052235	LCR	3M Company	EMA Dental Cement
21 Jul 2005	K051797	FUTURE WASH/YPS	3M Espe AG Dental Products	ELW Impression Material
15 Sep 2004	K042289	MDI ORTHO	Imtec Corp.	DZE Root-Form Endosseous Implant
11 Aug 2003	K032001	POLY Q (GARANT L, PENTA M, PENTA H)	3M Espe AG Dental Products	ELW Impression Material
2 Aug 2002	K022476	RELYX RMGIP	3M Company	EMA Dental Cement
12 Apr 2002	K020394	APC PLUS ADHESIVE	3M Unitek Corporation	DYH Resin Bracket and Tooth Conditioner Adhesive
29 Jun 2001	K011394	LAVA FRAME, LAVA FRAME SHADE, LAVA CERAM	Espe Dental AG	EIH Porcelain Powder
14 Jun 2001	K011200	GILB, MODEL 8010	3M Company	EMA Dental Cement
16 May 2001	K011154	ELIPAR FREELIGHT	Espe Dental AG	EBZ Ultraviolet Activator for Polymerization
13 Apr 2001	K010781	3M ESPE HAUR	3M Company	EBF Resin Tooth Shade Material
28 Sep 2000	K002452	3M RELY X VENEER CEMENT TRY-IN PASTER	3M Company	EMA Dental Cement
7 Jul 2000	K001494	MODIFICATION TO PROMPT L-POP	Espe Dental AG	KLE Resin Tooth Bonding Agent
5 Apr 2000	K000595	DIMENSION PENTA L	Espe Dental AG	ELW Impression Material
30 Mar 2000	K000591	DIMENSION PENTA H, DIMENSION PENTA H QUICK	Espe Dental AG	ELW Impression Material
30 Mar 2000	K000588	DIMENSION GARANT L, DIMENSION GARANT L QUICK	Espe Dental AG	ELW Impression Material
28 Jan 2000	K994193	IMPREGUM PENTA DUOSOFT	Espe Dental AG	ELW Impression Material
28 Jan 2000	K994192	IMPREGUM PENTA M MONOSOFT	Espe Dental AG	ELW Impression Material
27 Jan 2000	K994190	IMPREGUM GARANT L DUOSOFT	Espe Dental AG	ELW Impression Material
3 Jan 2000	K994251	KETAC-MOLAR QUICK	Espe Dental AG	EBF Resin Tooth Shade Material
8 Oct 1999	K992326	3M CLINPRO SEALANT	3M Company	EBC Pit and Fissure Sealant and Conditioner
8 Sep 1999	K992897	IMPREGUM PENTA	Espe Dental AG	ELW Impression Material
8 Sep 1999	K992895	IMPREGUM F	Espe Dental AG	ELW Impression Material
9 Aug 1999	K991961	3M LVR SYSTEM	3M Company	EBF Resin Tooth Shade Material
26 Jul 1999	K991913	PENTAMIX 2	Espe Dental AG	EFD Ac-Powered Dental Amalgamator
18 Jun 1999	K991008	DIMENSION BITE	Espe Dental AG	ELW Impression Material
8 Jan 1999	K984248	PROCEM	Espe Dental AG	EMA Dental Cement
9 Aug 1998	K981647	3M DENT II SYSTEM	3M Company	EBF Resin Tooth Shade Material
29 Jan 1998	K974231	POSITION PENTA, POSITION PENTA QUICK	Espe GmbH & Co. Kg.	ELW Impression Material
17 Dec 1997	K973961	3M DENT SYSTEM II PLUS	3M Company	EMA Dental Cement
17 Nov 1997	K973262	KETAC-FIL APLICAP PLUS	Espe GmbH & Co. Kg.	EMA Dental Cement
29 Aug 1997	K972355	3M AURORA SYSTEM	3M Company	EBZ Ultraviolet Activator for Polymerization
30 Apr 1997	K970500	3M SUSTEL DENTAL SYSTEM	3M Company	EBF Resin Tooth Shade Material
27 Nov 1996	K963735	COJET SYSTEM	Espe GmbH & Co. Kg.	EBF Resin Tooth Shade Material
31 Oct 1996	K963766	3M PROPLUS SYSTEM	3M Company	ELW Impression Material
12 Aug 1996	K962785	3M DENT SYSTEM	3M Company	KLE Resin Tooth Bonding Agent
16 May 1996	K960954	KETAC-MOLAR APLICAP	Espe GmbH & Co. Kg.	EMA Dental Cement
15 Mar 1996	K960547	DIMENSION PENTA/DIMENSION GARANT L/POLYVINYL SILOXANE ADHESIVE	Espe GmbH & Co. Kg.	ELW Impression Material
18 Aug 1995	K953374	PERMADYNE GARANT 2:1	Espe GmbH & Co. Kg.	ELW Impression Material
19 Jul 1995	K953027	PERMADYNE PENTA (HIGH & LOW VISCOSITY)	Espe GmbH & Co. Kg.	ELW Impression Material
7 Mar 1995	K950514	TRI-CURE GLASS IONOMER ORTHODONTIC BAND CEMENT	3M Unitek Corporation	DYH Resin Bracket and Tooth Conditioner Adhesive
29 Nov 1994	K944286	METAL-LINED TRANSCEND CERAMIC BRACKET	Unitek Corp.	DYW Orthodontic Plastic Bracket
16 May 1994	K941189	DISPOSABLE PROPHYLAXIS ANGLE	Team Technologies, Inc.	EGS Dental Contra- and Right-Angle Attachment Handpiece
5 Jan 1994	K933139	3M VITREMER LUTING CEMENT	3M Company	EMA Dental Cement
18 Jun 1993	K925027	PHOTAC-FIL APLICAP	Espe GmbH (Us)	EMA Dental Cement
23 Dec 1992	K925032	3M VITREMER TRI-CURE GLASS IONOMER SYSTEM	3M Company	EMA Dental Cement
25 Nov 1992	K924812	3M CURING LIGHT XL 3000	3M Company	EBZ Ultraviolet Activator for Polymerization
20 Mar 1992	K920425	3M BRAND RESTORATIVE Z100	3M Company	EBF Resin Tooth Shade Material
20 Mar 1992	K920424	SCOTCHBOND BRAND MULTI-PURPOSE ADHESIVE SYSTEM	3M Company	KLE Resin Tooth Bonding Agent
16 Dec 1991	K913857	ROCATEC(R) -PLUS	Espe GmbH (Us)	EJH Base Metal Alloy
4 Dec 1991	K913965	ESPE(R) -SIL	Espe GmbH (Us)	KLE Resin Tooth Bonding Agent
29 May 1991	K911271	ADHESIVE PRECOATED BRACKETS	Unitek Corp.	DYH Resin Bracket and Tooth Conditioner Adhesive
28 Mar 1990	K900436	PROTEMP II	Espe GmbH (Us)	EBG Resin Temporary Crown and Bridge
27 Mar 1990	K897188	KETAC-CEM MAXICAP	Espe GmbH (Us)	EMA Dental Cement
19 Jan 1989	K884752	KETAC-GLAZE	Espe GmbH (Us)	KLE Resin Tooth Bonding Agent
11 Aug 1988	K882690	IMPRINT VINYL POLYSILOXANE IMPRESSION MATERIAL	3M Company	ELW Impression Material
12 Apr 1988	K874788	KETAC-BOND APLICAP	Espe GmbH (Us)	EMA Dental Cement
31 Mar 1988	K880393	TRANSBOND LIGHT CURED ORTHODONTIC ADHESIVE	Unitek Corp.	DYH Resin Bracket and Tooth Conditioner Adhesive
9 Mar 1988	K875228	PERMADYNE ADHESIVE	Espe GmbH (Us)	EBH Resin Impression Tray Material
9 Mar 1988	K872984	KETAC-CONDITIONER	Espe GmbH (Us)	EMA Dental Cement
1 Mar 1988	K875133	CAVIT-W	Espe GmbH (Us)	EBG Resin Temporary Crown and Bridge
14 Nov 1985	K853698	SCOTCHPRIME CERAMIC PRIMER	3M Company	EIH Porcelain Powder
19 Aug 1985	K844845	ESPE KETAC-BOND	Espe GmbH (Us)	EBD Resin Filling Material Coating
25 Mar 1985	K844846	ESPE KETAC-CEM RADIOPAQUE	Espe GmbH (Us)	EMA Dental Cement
7 Jan 1985	K844211	CONCISE LIGHT CURED WHITE SEALANT	3M Company	EBC Pit and Fissure Sealant and Conditioner
6 Dec 1984	K843566	KETAC-SILVER	Espe GmbH (Us)	EMA Dental Cement
12 Jan 1982	K813180	SCOTCHBOND DENTAL ADHESIVE	3M Company	KLE Resin Tooth Bonding Agent
23 Feb 1981	K810266	ETCHING GEL	Espe-Premier Sales Co.	EJK Calcium Hydroxide Cavity Liner
18 Mar 1980	K800485	VINYL POLYSILOXANE IMPRESSION MATERIAL	3M Company	ELW Impression Material
5 Feb 1980	K800031	PERMADYNE POLYETHER RUBBER IMPRESSION	Espe Dental Products	ELW Impression Material
16 Aug 1977	K771451	SCUTABOND	Premier Dental Products Company	EMA Dental Cement

Registered establishments

Establishment	Location	What it does
Solventum Germany GmbHFDA reg. 9611385	SEEFELD Bavaria, Germany	Complaint file establishment, Contract manufacturer, Manufacturer, Repacker / relabeler, Specification developer
Solventum Germany GmbHFDA reg. 3035693034	Kist Bavaria, Germany	Foreign exporter
Solventum Germany GmbHFDA reg. 3032911850	Kamen North Rhine-Westphalia, Germany	Complaint file establishment, Manufacturer, Specification developer
Solventum Orthodontics CorporationFDA reg. 3032027578	Monrovia, CA, United States	Complaint file establishment, Contract manufacturer, Manufacturer for export, Manufacturer, Repacker / relabeler, Specification developer
Solventum Poland Manufacturing SP. ZO.OFDA reg. 3032763783	Wroclaw Dolnoslaskie, Poland	Manufacturer
Solventum US LLCFDA reg. 3031841433	San Antonio, TX, United States	Complaint file establishment, Contract manufacturer, Manufacturer for export, Manufacturer, Specification developer
Solventum US LLCFDA reg. 3032163716	Irvine, CA, United States	Contract manufacturer, Manufacturer, Repacker / relabeler
SOLVENTUM US LLCFDA reg. 3042272797	Eagan, MN, United States	Complaint file establishment, Contract manufacturer, Manufacturer, Specification developer

Other names on FDA records

Solventum Germany GmbH · Solventum Orthodontics Corporation · Solventum Poland Manufacturing Sp z o.o.

Sources

FDA establishment registration & device listing (search FDA, owner/operator 10091183). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.