Solventum Germany GmbH

FDA Device Registration & Listing · Kist Bavaria, DE · Registration 3035693034

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
3035693034
FEI Number
3035693034
Entity Name
Solventum Germany GmbH
City/State/Country
Kist Bavaria, DE
Establishment Address
Ringstrasse 14, Kist Bavaria 97270, DE
Establishment Type(s)
Export Device to the United States But Perform No Other Operation on 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
K810266
PMA Number
N/A

All Registered Proprietary Names

Burs VPS Tray Adhesive CROWN OPTICLUDE ORTHOPTIC EYE PATCH OPTICLUDE 3M¿ Nexcare¿ Opticlude Orthoptic Eye Patch 3M(TM) Nexcare(TM) Gentle Removal Eye Patch

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
EMA Cement, Dental Dental Class 2 872.3275 2008-12-10
ELW Material, Impression Dental Class 2 872.3660 2008-12-11
ELW Material, Impression Dental Class 2 872.3660 2011-06-09
EBG Crown And Bridge, Temporary, Resin Dental Class 2 872.3770 2008-12-10
MVL Cord, Retraction Unknown Class U N/A 2010-04-28
ELW Material, Impression Dental Class 2 872.3660 2013-06-12
DZA Drill, Dental, Intraoral Dental Class 1 872.4130 2006-06-20
EBD Coating, Filling Material, Resin Dental Class 2 872.3310 2008-12-10
ELW Material, Impression Dental Class 2 872.3660 2008-12-11
EMA Cement, Dental Dental Class 2 872.3275 2011-06-08
EMA Cement, Dental Dental Class 2 872.3275 2019-11-06
EBG Crown And Bridge, Temporary, Resin Dental Class 2 872.3770 2008-07-09
EMA Cement, Dental Dental Class 2 872.3275 2008-12-10
EID Syringe, Restorative And Impression Material Dental Class 1 872.4565 1978-08-31
EFD Amalgamator, Dental, Ac-Powered Dental Class 1 872.3100 2008-12-10
EHY Tray, Impression, Preformed Dental Class 1 872.6880 2000-09-07
EMA Cement, Dental Dental Class 2 872.3275 2010-07-05
PIP Prophy Powder, Airbrush Accessory Dental Class 2 872.6080 2014-11-04
ELW Material, Impression Dental Class 2 872.3660 2008-12-11
ELW Material, Impression Dental Class 2 872.3660 2008-12-11
EMA Cement, Dental Dental Class 2 872.3275 2008-12-10
EIR Scissors, Collar And Crown Dental Class 1 872.4565 2025-02-21
EJL Bur, Dental Dental Class 1 872.3240 2003-11-26
ELW Material, Impression Dental Class 2 872.3660 2008-12-11
EBF Material, Tooth Shade, Resin Dental Class 2 872.3690 2012-03-07
ELW Material, Impression Dental Class 2 872.3660 2008-12-11
ELW Material, Impression Dental Class 2 872.3660 1977-12-15
ELW Material, Impression Dental Class 2 872.3660 2012-06-26
DZN Instruments, Dental Hand Dental Class 1 872.4565 2001-08-06
ELW Material, Impression Dental Class 2 872.3660 2008-12-11
EBH Material, Impression Tray, Resin Dental Class 1 872.3670 2008-12-12
ELZ Crown, Preformed Dental Class 1 872.3330 2001-08-06
ELW Material, Impression Dental Class 2 872.3660 2008-07-02
EJH Alloy, Metal, Base Dental Class 2 872.3710 2008-12-10
EMA Cement, Dental Dental Class 2 872.3275 2008-12-10
EIH Powder, Porcelain Dental Class 2 872.6660 2012-01-26
EMA Cement, Dental Dental Class 2 872.3275 2008-12-10
HOY Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) Ophthalmic Class 1 886.4750 1978-03-31
ELW Material, Impression Dental Class 2 872.3660 2008-12-11
EMA Cement, Dental Dental Class 2 872.3275 2012-06-29
EBF Material, Tooth Shade, Resin Dental Class 2 872.3690 2008-12-10
KLE Agent, Tooth Bonding, Resin Dental Class 2 872.3200 2007-11-28
ELW Material, Impression Dental Class 2 872.3660 2014-08-05
EHJ Disk, Abrasive Dental Class 1 872.6010 2001-06-12
ELW Material, Impression Dental Class 2 872.3660 2008-12-12
KLE Agent, Tooth Bonding, Resin Dental Class 2 872.3200 2008-12-10
EMA Cement, Dental Dental Class 2 872.3275 2016-04-14
EMA Cement, Dental Dental Class 2 872.3275 2008-12-10
EJK Liner, Cavity, Calcium Hydroxide Dental Class 2 872.3250 2011-05-25

Official Correspondent

JEFFERY SCHORR

US Agent Details

JEFFERY SCHORR Business: SOLVENTUM US LLC Email: RegulatoryRequests@solventum.com Phone: (210) 2556721

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
K972485 Arent, Fox, Kintner, Plotkin & Kahn CIMPAT N 1997-09-08
K982895 Sterngold/Implamed STERNOMEGA COMPOMER CEMENT 1998-10-09
K033068 Voco GmbH IONOFIL COLOR AC 2003-10-31
K062064 Southern Dental Industries, Inc. RIVA BOND LC 2006-11-09
K940030 Bisco, Inc. BISCO COMPOSITE 1994-02-04

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-0017-2017 Ivoclar Vivadent, Inc. 2
Zenostar MT Color Impulse blue, Art. no. 681165 Product Usage: For coloring dental porcelain
Z-0018-2017 Ivoclar Vivadent, Inc. 2
Zenostar MT Color Impulse brown, art. no. 681169 Product Usage: For coloring dental porcelain
Z-0019-2017 Ivoclar Vivadent, Inc. 2
Zenostar MT Color Impulse grey, art. no. 681167 Product Usage: For coloring dental porcelain
Z-0020-2017 Ivoclar Vivadent, Inc. 2
Zenostar MT Color Impulse violet, art. no. 681166 Product Usage: For coloring dental porcelain

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3035693034. Last updated year: 2026. Please use registration number 3035693034 when referencing this establishment in official correspondence.
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