Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3042272797

FEI Number

3042272797

Entity Name

SOLVENTUM US LLC

City/State/Country

Eagan, MN, US

Establishment Address

1750 Yankee Doodle Rd, Eagan, MN 55121, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

Solventum US LLC (Owner Number: 10091183)

Owner / Operator Contact Address

12930 IH 10 West, San Antonio, TX 78249, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K220942

PMA Number

N/A

All Registered Proprietary Names

3M Red Dot Electrodes 3M Electrosurgical Patient Plates Liquid Bandage Drops 3M SURGICAL CLIPPER 3M Electrosurgical Patient Plate 3M Defib Pads 3M Littmann TeleSteth Online Auscultation System 3M¿ Steri-Vac¿ XL Aeration Cabinet Attest Rapid Readout 1291 3M Electrosurgical Patient Plates 3M Universal Electrosurgical Pad 3M 3M¿ Attest¿ Auto-Reader 3M Electrosurgical Patient Plate 3M¿ Ioban¿ 2 3M¿ Steri-Drape¿ Ioban¿ 2 3M 3M 3M

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2012-03-29
LGZ	Warmer, Thermal, Infusion Fluid	General Hospital	Class 2	880.5725	2013-01-17
LDE	Stethoscope, Manual	Cardiovascular	Class 1	870.1875	2003-10-22
FXX	Mask, Surgical	General, Plastic Surgery	Class 2	878.4040	2019-11-13
DZN	Instruments, Dental Hand	Dental	Class 1	872.4565	2001-08-06
FRC	Indicator, Biological Sterilization Process	General Hospital	Class 2	880.2800	2021-07-12
JOJ	Indicator, Physical/Chemical Sterilization Process	General Hospital	Class 2	880.2800	2021-07-12
OXQ	Dressing Change Tray	General Hospital	Class 1	880.5075	2015-02-05
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2009-05-11
FRC	Indicator, Biological Sterilization Process	General Hospital	Class 2	880.2800	2025-07-15
EMA	Cement, Dental	Dental	Class 2	872.3275	2007-12-05
FRC	Indicator, Biological Sterilization Process	General Hospital	Class 2	880.2800	2018-05-31
EMA	Cement, Dental	Dental	Class 2	872.3275	2008-02-14
LBH	Varnish, Cavity	Dental	Class 2	872.3260	2008-02-14
EJK	Liner, Cavity, Calcium Hydroxide	Dental	Class 2	872.3250	2008-02-14
EBC	Sealant, Pit And Fissure, And Conditioner	Dental	Class 2	872.3765	2008-02-14
DWJ	System, Thermal Regulating	Cardiovascular	Class 2	870.5900	2013-01-17
SEL	Securement Wound Dressing For Reduction Of Infection	Unknown	Class U	N/A	2019-11-21
EBG	Crown And Bridge, Temporary, Resin	Dental	Class 2	872.3770	2011-02-17
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2011-02-17
PUI	Drape, Surgical, Exempt	General, Plastic Surgery	Class 2	878.4370	2017-08-07
DRX	Electrode, Electrocardiograph	Cardiovascular	Class 2	870.2360	2008-04-11
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2007-12-28
KCQ	Tube Impression And Matrix	Dental	Class 1	872.6570	2025-06-26
KMF	Bandage, Liquid	General Hospital	Class 1	880.5090	2007-12-06
JOJ	Indicator, Physical/Chemical Sterilization Process	General Hospital	Class 2	880.2800	2013-04-25
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2007-12-06
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2007-12-06
KMF	Bandage, Liquid	General Hospital	Class 1	880.5090	2007-12-07
FLF	Sterilizer, Ethylene-Oxide Gas	General Hospital	Class 2	880.6860	2015-02-06
LBH	Varnish, Cavity	Dental	Class 2	872.3260	2023-05-15
FRC	Indicator, Biological Sterilization Process	General Hospital	Class 2	880.2800	2020-04-24
KXR	Applicator, Resin	Dental	Class 1	872.3140	2001-02-26
EMA	Cement, Dental	Dental	Class 2	872.3275	2007-12-05
IQJ	Splint, Clavicle	Physical Medicine	Class 1	890.3490	2021-06-18
EMA	Cement, Dental	Dental	Class 2	872.3275	2007-12-05
FRC	Indicator, Biological Sterilization Process	General Hospital	Class 2	880.2800	2007-12-05
PLY	Antimicrobial Drapes	General, Plastic Surgery	Class 2	878.4370	2024-07-10
KKX	Drape, Surgical, Antimicrobial	General, Plastic Surgery	Class 2	878.4370	2024-07-10
JOJ	Indicator, Physical/Chemical Sterilization Process	General Hospital	Class 2	880.2800	2024-11-19
QKM	A Chemical Vapor Sterilization Multivariable Chemical Indicator	General Hospital	Class 2	880.2800	2022-09-06
NDP	Accessories, Implant, Dental, Endosseous	Dental	Class 1	872.3980	2011-05-26
EID	Syringe, Restorative And Impression Material	Dental	Class 1	872.4565	1978-08-31
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2019-01-04
LWK	Razor, Surgical	General, Plastic Surgery	Class 1	878.4800	1995-02-13
FRC	Indicator, Biological Sterilization Process	General Hospital	Class 2	880.2800	2018-05-31
EJY	Pliers, Operative	Dental	Class 1	872.4565	2001-08-06
EMA	Cement, Dental	Dental	Class 2	872.3275	2013-06-26
QBP	Cap, Device Disinfectant	General Hospital	Class 2	880.5440	2019-04-01
JOJ	Indicator, Physical/Chemical Sterilization Process	General Hospital	Class 2	880.2800	2022-11-15
FRC	Indicator, Biological Sterilization Process	General Hospital	Class 2	880.2800	2025-05-22
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2013-01-22
KGY	Bag, Intestine	General, Plastic Surgery	Class 1	878.4100	2004-01-28
FRC	Indicator, Biological Sterilization Process	General Hospital	Class 2	880.2800	2007-12-05
EMA	Cement, Dental	Dental	Class 2	872.3275	2011-05-18
FXX	Mask, Surgical	General, Plastic Surgery	Class 2	878.4040	2019-11-13
FRC	Indicator, Biological Sterilization Process	General Hospital	Class 2	880.2800	2007-12-05
FRC	Indicator, Biological Sterilization Process	General Hospital	Class 2	880.2800	2007-12-05
HKT	Prism, Fresnel, Ophthalmic	Ophthalmic	Class 1	886.1655	2025-02-12
KGT	Drape, Adhesive, Aerosol	General, Plastic Surgery	Class 1	878.4380	2012-05-18
EHJ	Disk, Abrasive	Dental	Class 1	872.6010	2001-06-12
FQM	Bandage, Elastic	General Hospital	Class 1	880.5075	2024-10-29
EBC	Sealant, Pit And Fissure, And Conditioner	Dental	Class 2	872.3765	2022-06-23
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2022-06-23
GYB	Media, Electroconductive	Neurology	Class 2	882.1275	2007-12-06
LXZ	Guard, Instrument	General, Plastic Surgery	Class 1	878.4800	2007-12-05
DRG	Transmitters And Receivers, Physiological Signal, Radiofrequency	Cardiovascular	Class 2	870.2910	2012-07-12
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2007-12-06
FLI	Cabinet, Ethylene-Oxide Gas Aerator	General Hospital	Class 2	880.6100	2007-12-06
EJQ	Wheel, Polishing Agent	Dental	Class 1	872.6010	1992-06-29
FRC	Indicator, Biological Sterilization Process	General Hospital	Class 2	880.2800	2007-12-11
JOJ	Indicator, Physical/Chemical Sterilization Process	General Hospital	Class 2	880.2800	2010-01-27
FMP	Protector, Skin Pressure	General Hospital	Class 1	880.6450	2025-02-21
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2007-12-14
EMA	Cement, Dental	Dental	Class 2	872.3275	2007-12-05
JTQ	Bath, Incubators/Water, All	Microbiology	Class 1	866.2540	1995-03-02
NAD	Dressing, Wound, Occlusive	General, Plastic Surgery	Class 1	878.4020	2004-01-28
ELW	Material, Impression	Dental	Class 2	872.3660	2007-12-06
JOJ	Indicator, Physical/Chemical Sterilization Process	General Hospital	Class 2	880.2800	2022-06-02
HMP	Pad, Eye	General, Plastic Surgery	Class 1	878.4440	2025-04-17
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2007-12-07
EYY	Drape, Urological, Disposable	General, Plastic Surgery	Class 2	878.4370	2020-07-07
FRC	Indicator, Biological Sterilization Process	General Hospital	Class 2	880.2800	2022-11-15
KMK	Device, Intravascular Catheter Securement	General Hospital	Class 1	880.5210	2004-01-28
ITG	Bandage, Cast	Physical Medicine	Class 1	890.3025	2002-07-11
GDT	Staple, Removable (Skin)	General, Plastic Surgery	Class 1	878.4760	1995-03-03
FRC	Indicator, Biological Sterilization Process	General Hospital	Class 2	880.2800	2007-12-05
EJK	Liner, Cavity, Calcium Hydroxide	Dental	Class 2	872.3250	2023-02-07
JOJ	Indicator, Physical/Chemical Sterilization Process	General Hospital	Class 2	880.2800	2022-04-05
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2007-12-14
FRC	Indicator, Biological Sterilization Process	General Hospital	Class 2	880.2800	2013-03-26
PEZ	Central Venous Catheter Dressing Change Kit	General Hospital	Class 2	880.5200	2014-12-12
EIF	Accessories, Retractor, Dental	Dental	Class 1	872.4565	1978-08-31
LBH	Varnish, Cavity	Dental	Class 2	872.3260	2017-04-05
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2015-04-20
JOJ	Indicator, Physical/Chemical Sterilization Process	General Hospital	Class 2	880.2800	1997-02-20
FRC	Indicator, Biological Sterilization Process	General Hospital	Class 2	880.2800	2025-07-21
JOJ	Indicator, Physical/Chemical Sterilization Process	General Hospital	Class 2	880.2800	2007-12-05
KLE	Agent, Tooth Bonding, Resin	Dental	Class 2	872.3200	2007-12-06
IME	Pack, Hot Or Cold, Reusable	Physical Medicine	Class 1	890.5700	2024-07-18
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2013-01-17
QBP	Cap, Device Disinfectant	General Hospital	Class 2	880.5440	2019-04-01
BSB	Warmer, Blood, Non-Electromagnetic Radiation	Hematology	Class 2	864.9205	2013-01-17
DWJ	System, Thermal Regulating	Cardiovascular	Class 2	870.5900	2021-09-17
EMA	Cement, Dental	Dental	Class 2	872.3275	2007-12-05
DWJ	System, Thermal Regulating	Cardiovascular	Class 2	870.5900	2021-09-17
KLE	Agent, Tooth Bonding, Resin	Dental	Class 2	872.3200	2007-12-06
FRC	Indicator, Biological Sterilization Process	General Hospital	Class 2	880.2800	2025-07-21
EBC	Sealant, Pit And Fissure, And Conditioner	Dental	Class 2	872.3765	2007-12-06
KKX	Drape, Surgical, Antimicrobial	General, Plastic Surgery	Class 2	878.4370	2007-12-06
JOJ	Indicator, Physical/Chemical Sterilization Process	General Hospital	Class 2	880.2800	2025-04-15
EIR	Scissors, Collar And Crown	Dental	Class 1	872.4565	2025-02-21
ELW	Material, Impression	Dental	Class 2	872.3660	2007-12-06
KGW	Ring (Wound Protector), Drape Retention, Internal	General, Plastic Surgery	Class 2	878.4370	2020-07-07
FRL	Fiber, Medical, Absorbent	General Hospital	Class 1	880.5300	2003-09-26
NAC	Dressing, Wound, Hydrophilic	General, Plastic Surgery	Class 1	878.4018	2004-01-28
FQZ	Thermometer, Clinical Color Change	General Hospital	Class 1	880.2900	1997-01-13
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2007-12-05
EGS	Handpiece, Contra- And Right-Angle Attachment, Dental	Dental	Class 1	872.4200	2007-12-07
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2010-05-14
EBC	Sealant, Pit And Fissure, And Conditioner	Dental	Class 2	872.3765	2007-12-06
QBP	Cap, Device Disinfectant	General Hospital	Class 2	880.5440	2021-04-19
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2009-07-31
JOJ	Indicator, Physical/Chemical Sterilization Process	General Hospital	Class 2	880.2800	2022-09-06

Official Correspondent

JEFFERY SCHORR

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Solventum US LLC

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3004943440	3M Purification, S. de R.L. de C. V.	San Luis Potosi Mexico, MX
3003775292	KCI POLYMEDICS BV	PEER Limburg, BE
3036108847	Solventum US LLC	Eden Prairie, MN, US
3038988287	Solventum Canada Limited	Morden Manitoba, CA
3032763783	Solventum Poland Manufacturing SP. ZO.O	Wroclaw Dolnoslaskie, PL

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K952662	Jeneric/Pentron, Inc.	COMP=FLOW	1995-08-28
K171147	Bisco, Inc.	REVEAL Bulk	2017-08-04
K770922	Espe GmbH (Us)	DENTAL RESTORATIVE IN CAPSULES	1977-06-01
K153476	Kuraray Noritake Dental, Inc.	KATANA AVENCIA Block	2016-08-23
K201622	Guangdong Kingfa Sci. & Tech.Co., Ltd.	Medical surgical mask	2020-11-24

Related Recall Records

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Z-0028-2020	Voco GmbH Anton-Flettner-Str. 1-3 Cuxhaven Germany	2	Grandio SO Heavy Flow Caps, Color A3 - Product Usage: Filling minimally invasive cavities of all classes - Filling small class I cavities and extended fissure sealing - Filling class II - V cavities including V-shaped defects and cervical caries - Blocking out undercuts - Lining or coating cavities - Repairing fillings and veneers - Luting translucent prosthetic pieces (e.g., full ceramic crowns, etc.).
Z-0027-2007	N/A	2	3M Comply 1248 Gas Plasma Chemical Indicator Strips for use in STERRAD 100, STERRAD 100S and STERRAD 50 Sterilization Systems. Indicator for hydrogen peroxide sterilant.
Z-0035-2010	Cincinnati Sub-Zero Products Inc	2	WarmAir 135 Thermal Regulating System. Catalog Numbers: 86186-115 V, 06186-115 V (sold in the U.S.) and #86185-100 V ( not sold in the U.S.). Intended for warming patients before, during and after surgery, and other specialty procedures.
Z-0031-06	Rita Medical Systems	2	Rita Brand Habib 4X Electrosurgical Coagulator, Catalog Number: 4401US; Product is distributed by RITA Medical Systems, Inc., One Horizon Way. Manchester, GA 32826
Z-0022-2013	3M Company Health Care Business 3M Center	2	3M Steri-Vac Gas Sterilizer/Aerator models 5XL and 8XL. 3M Steri-Vac Gas Sterilizer/Aerator is a compact unit designed to sterilize heat- and/or moisture-sensitive devices. This gas sterilizer/aerator is intended for indoor use only.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3042272797. Last updated year: 2026. Please use registration number 3042272797 when referencing this establishment in official correspondence.