Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9611385

FEI Number

3002806930

Entity Name

Solventum Germany GmbH

City/State/Country

SEEFELD Bavaria, DE

Establishment Address

ESPE PLATZ, SEEFELD Bavaria 82229, DE

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

Expiration Date (Year)

2026

510(k) Number

K953027

PMA Number

N/A

All Registered Proprietary Names

Impregum Penta Soft MB VPS Tray Adhesive

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ELW	Material, Impression	Dental	Class 2	872.3660	2017-10-31
DZA	Drill, Dental, Intraoral	Dental	Class 1	872.4130	2006-06-20
ELW	Material, Impression	Dental	Class 2	872.3660	2008-12-11
EBD	Coating, Filling Material, Resin	Dental	Class 2	872.3310	2008-12-10
KLE	Agent, Tooth Bonding, Resin	Dental	Class 2	872.3200	2011-05-25
EMA	Cement, Dental	Dental	Class 2	872.3275	2008-12-10
ELW	Material, Impression	Dental	Class 2	872.3660	2008-12-11
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2012-03-07
KLE	Agent, Tooth Bonding, Resin	Dental	Class 2	872.3200	2008-12-10
ELW	Material, Impression	Dental	Class 2	872.3660	2011-06-09
EJH	Alloy, Metal, Base	Dental	Class 2	872.3710	2008-12-10
EMA	Cement, Dental	Dental	Class 2	872.3275	2005-07-19
EBG	Crown And Bridge, Temporary, Resin	Dental	Class 2	872.3770	2008-07-09
ELW	Material, Impression	Dental	Class 2	872.3660	2011-06-09
EHJ	Disk, Abrasive	Dental	Class 1	872.6010	2001-06-12
EMA	Cement, Dental	Dental	Class 2	872.3275	2019-11-06
EID	Syringe, Restorative And Impression Material	Dental	Class 1	872.4565	1978-08-31
MVL	Cord, Retraction	Unknown	Class U	N/A	2010-04-28
ELW	Material, Impression	Dental	Class 2	872.3660	1977-12-15
EMA	Cement, Dental	Dental	Class 2	872.3275	2008-12-10
ELW	Material, Impression	Dental	Class 2	872.3660	2008-12-11
EMA	Cement, Dental	Dental	Class 2	872.3275	2016-04-14
EMA	Cement, Dental	Dental	Class 2	872.3275	2010-06-15
EIR	Scissors, Collar And Crown	Dental	Class 1	872.4565	2025-02-21
KLE	Agent, Tooth Bonding, Resin	Dental	Class 2	872.3200	2007-11-28
EBH	Material, Impression Tray, Resin	Dental	Class 1	872.3670	2008-12-12
KLE	Agent, Tooth Bonding, Resin	Dental	Class 2	872.3200	2008-12-10
ELW	Material, Impression	Dental	Class 2	872.3660	2022-03-25
ELR	Post, Root Canal	Dental	Class 1	872.3810	2006-03-01
EBZ	Activator, Ultraviolet, For Polymerization	Dental	Class 2	872.6070	2008-02-25
EMA	Cement, Dental	Dental	Class 2	872.3275	2008-12-10
ELW	Material, Impression	Dental	Class 2	872.3660	2008-07-02
EJK	Liner, Cavity, Calcium Hydroxide	Dental	Class 2	872.3250	2011-05-25
EMA	Cement, Dental	Dental	Class 2	872.3275	2011-06-08
PIP	Prophy Powder, Airbrush Accessory	Dental	Class 2	872.6080	2014-11-04
EMA	Cement, Dental	Dental	Class 2	872.3275	2010-07-05
ELW	Material, Impression	Dental	Class 2	872.3660	2008-12-12
EMA	Cement, Dental	Dental	Class 2	872.3275	2008-12-10
ELW	Material, Impression	Dental	Class 2	872.3660	2008-12-11
EMA	Cement, Dental	Dental	Class 2	872.3275	2008-12-10
EIH	Powder, Porcelain	Dental	Class 2	872.6660	2008-12-10
EMA	Cement, Dental	Dental	Class 2	872.3275	2008-12-10
EBG	Crown And Bridge, Temporary, Resin	Dental	Class 2	872.3770	2008-12-10
KLE	Agent, Tooth Bonding, Resin	Dental	Class 2	872.3200	2008-12-10
QGO	Composite Resin Warmer	Dental	Class 1	872.6100	2025-04-01
ELW	Material, Impression	Dental	Class 2	872.3660	2012-06-26
ELW	Material, Impression	Dental	Class 2	872.3660	2008-12-11
EMA	Cement, Dental	Dental	Class 2	872.3275	2008-12-10
ELW	Material, Impression	Dental	Class 2	872.3660	2008-12-11
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2008-12-10
ELW	Material, Impression	Dental	Class 2	872.3660	2008-12-11
EBG	Crown And Bridge, Temporary, Resin	Dental	Class 2	872.3770	2008-12-10
EBZ	Activator, Ultraviolet, For Polymerization	Dental	Class 2	872.6070	2007-12-06
KXR	Applicator, Resin	Dental	Class 1	872.3140	2001-02-26
ELW	Material, Impression	Dental	Class 2	872.3660	2011-06-09
ELW	Material, Impression	Dental	Class 2	872.3660	2014-03-07
KLE	Agent, Tooth Bonding, Resin	Dental	Class 2	872.3200	2007-11-28
EBZ	Activator, Ultraviolet, For Polymerization	Dental	Class 2	872.6070	2007-11-28
EMA	Cement, Dental	Dental	Class 2	872.3275	2012-06-29
ELW	Material, Impression	Dental	Class 2	872.3660	2008-12-11
ELW	Material, Impression	Dental	Class 2	872.3660	2013-06-12
ELW	Material, Impression	Dental	Class 2	872.3660	2008-12-11

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

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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
K952614	Dentsply Intl.	JELTRATE PLUS ANTIMICROBIAL IMPR. MATERIAL	1996-08-13
K093019	Enamelite, LLC	ENAMELITE ACRYSEAL SPRAY SEALANT	2009-12-22
K030585	Bisco, Inc.	SCULPTING RESIN	2003-04-28
K790438	Vivadent (Usa), Inc.	COLORANT	1979-04-10
K901050	Pulpdent Corp.	NO-STICK COMPOSITE INSTRUMENT DIP	1990-04-19

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
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-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

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9611385. Last updated year: 2026. Please use registration number 9611385 when referencing this establishment in official correspondence.