Solventum US LLC

FDA Device Registration & Listing · Irvine, CA, US · Registration 3032163716

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3032163716
FEI Number
3032163716
Entity Name
Solventum US LLC
City/State/Country
Irvine, CA, US
Establishment Address
2111 McGaw Avenue, Irvine, CA 92614, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Solventum US LLC (Owner Number: 10091183)
Owner / Operator Contact Address
12930 IH 10 West, San Antonio, TX 78249, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
PMA Number
N/A

All Registered Proprietary Names

CROWN Burs Transbond Supreme LV Light Cure Adhesive Transbond Supreme LV Adhesive, Transbond Supreme Adhesive, Transbond Supreme Low Viscosity Adh Unitek Multi-Cure Glass Ionomer Orthodontic Band Cement

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 2019-01-04
EBF Material, Tooth Shade, Resin Dental Class 2 872.3690 2010-05-14
KLE Agent, Tooth Bonding, Resin Dental Class 2 872.3200 2007-11-28
EJQ Wheel, Polishing Agent Dental Class 1 872.6010 1992-06-29
EBF Material, Tooth Shade, Resin Dental Class 2 872.3690 2014-05-13
EBF Material, Tooth Shade, Resin Dental Class 2 872.3690 2009-05-11
EMA Cement, Dental Dental Class 2 872.3275 2007-12-05
EBF Material, Tooth Shade, Resin Dental Class 2 872.3690 2007-12-05
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
EJF Bracket, Metal, Orthodontic Dental Class 1 872.5410 2007-11-27
DYH Adhesive, Bracket And Tooth Conditioner, Resin Dental Class 2 872.3750 2007-11-27
DYW Bracket, Plastic, Orthodontic Dental Class 2 872.5470 2007-11-27
EBF Material, Tooth Shade, Resin Dental Class 2 872.3690 2007-12-06
EBF Material, Tooth Shade, Resin Dental Class 2 872.3690 2016-12-13
EBC Sealant, Pit And Fissure, And Conditioner Dental Class 2 872.3765 2007-12-06
NDP Accessories, Implant, Dental, Endosseous Dental Class 1 872.3980 2011-05-26
EJF Bracket, Metal, Orthodontic Dental Class 1 872.5410 2012-02-07
DYH Adhesive, Bracket And Tooth Conditioner, Resin Dental Class 2 872.3750 2012-02-07
NJM Bracket, Ceramic, Orthodontic Dental Class 2 872.5470 2012-02-07
EIF Accessories, Retractor, Dental Dental Class 1 872.4565 1978-08-31
EMA Cement, Dental Dental Class 2 872.3275 2007-12-05
KXR Applicator, Resin Dental Class 1 872.3140 2001-02-26
EJK Liner, Cavity, Calcium Hydroxide Dental Class 2 872.3250 2011-05-25
LBH Varnish, Cavity Dental Class 2 872.3260 2023-05-15
EMA Cement, Dental Dental Class 2 872.3275 2007-12-05
ECO Spring, Orthodontic Dental Class 1 872.5410 2024-09-19
EBZ Activator, Ultraviolet, For Polymerization Dental Class 2 872.6070 2008-02-25
EMA Cement, Dental Dental Class 2 872.3275 2007-12-05
EIH Powder, Porcelain Dental Class 2 872.6660 2011-03-16
EBF Material, Tooth Shade, Resin Dental Class 2 872.3690 2007-12-06
EBC Sealant, Pit And Fissure, And Conditioner Dental Class 2 872.3765 2007-12-06
KCQ Tube Impression And Matrix Dental Class 1 872.6570 2025-06-26
ELZ Crown, Preformed Dental Class 1 872.3330 2001-08-06
KLE Agent, Tooth Bonding, Resin Dental Class 2 872.3200 2007-12-06
EMA Cement, Dental Dental Class 2 872.3275 2011-05-18
EBF Material, Tooth Shade, Resin Dental Class 2 872.3690 2012-03-29
EJL Bur, Dental Dental Class 1 872.3240 2003-11-26
KLE Agent, Tooth Bonding, Resin Dental Class 2 872.3200 2007-12-06
DZN Instruments, Dental Hand Dental Class 1 872.4565 2001-08-06
DYH Adhesive, Bracket And Tooth Conditioner, Resin Dental Class 2 872.3750 2008-04-21
ELW Material, Impression Dental Class 2 872.3660 2007-12-06
DYH Adhesive, Bracket And Tooth Conditioner, Resin Dental Class 2 872.3750 2007-11-27
LBH Varnish, Cavity Dental Class 2 872.3260 2010-04-16
EBF Material, Tooth Shade, Resin Dental Class 2 872.3690 2007-11-28
EHJ Disk, Abrasive Dental Class 1 872.6010 2001-06-12
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2010-07-15
EBZ Activator, Ultraviolet, For Polymerization Dental Class 2 872.6070 2007-12-06
EMA Cement, Dental Dental Class 2 872.3275 2007-12-05
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

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
K020499 Jeneric/Pentron, Inc. BOND-3 ADHESIVE 2002-04-22

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
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-0035-2008 Heraeus Kulzer Inc., Dental Products Division 2
Heraeus Kulzer GLUMA Comfort Bond + Desensitizer light curing one component adhesive, contents: 4 ml, dental bonding agent. Distributed by Heraeus Kulzer, Inc., Armonk, NY; Reorder No. 66001710.
Z-0036-2008 Heraeus Kulzer Inc., Dental Products Division 2
Heraeus Kulzer GLUMA Comfort Bond + Desensitizer light curing one component adhesive, Assortment Value Pack 3 x 4 ml, dental bonding agent. Distributed by Heraeus Kulzer, Inc., Armonk, NY; Reorder No. 66018222.
Z-0013-2022 Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel 1
Scan Abutment SP, Cat. No. 30-70101 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The Paltop Advanced Dental Solutions Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient s chewing function.
Z-0014-2022 Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel 1
Scan Abutment NP, Cat. No. 30-70102 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The Paltop Advanced Dental Solutions Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient s chewing function.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3032163716. Last updated year: 2026. Please use registration number 3032163716 when referencing this establishment in official correspondence.
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