Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3032911850

FEI Number

3032911850

Entity Name

Solventum Germany GmbH

City/State/Country

Kamen North Rhine-Westphalia, DE

Establishment Address

Edisonstrasse 6, Kamen North Rhine-Westphalia 59174, DE

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

K123679

PMA Number

N/A

All Registered Proprietary Names

Incognito Indirect Bonding Tray Incognito Hi-T Unitek 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
EBH	Material, Impression Tray, Resin	Dental	Class 1	872.3670	1999-03-19
EJF	Bracket, Metal, Orthodontic	Dental	Class 1	872.5410	1992-12-03
NAD	Dressing, Wound, Occlusive	General, Plastic Surgery	Class 1	878.4020	2004-01-28
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2026-05-18
OMP	Negative Pressure Wound Therapy Powered Suction Pump	General, Plastic Surgery	Class 2	878.4780	2026-05-18
DZD	Tube, Orthodontic	Dental	Class 1	872.5410	1992-12-03
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2019-11-15
FQM	Bandage, Elastic	General Hospital	Class 1	880.5075	2024-10-29
ELR	Post, Root Canal	Dental	Class 1	872.3810	2006-03-01
DZC	Wire, Orthodontic	Dental	Class 1	872.5410	1992-12-03
KGN	Wound Dressing With Animal-Derived Material(S)	Unknown	Class U	N/A	2019-11-15
NAE	Dressing, Wound, Hydrogel Without Drug And/Or Biologic	General, Plastic Surgery	Class 1	878.4022	2004-01-28
FMP	Protector, Skin Pressure	General Hospital	Class 1	880.6450	2025-02-21
ELW	Material, Impression	Dental	Class 2	872.3660	2008-12-11
KGN	Wound Dressing With Animal-Derived Material(S)	Unknown	Class U	N/A	2019-11-15
NAC	Dressing, Wound, Hydrophilic	General, Plastic Surgery	Class 1	878.4018	2004-01-28
EJK	Liner, Cavity, Calcium Hydroxide	Dental	Class 2	872.3250	2011-05-25
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2022-04-04
EBG	Crown And Bridge, Temporary, Resin	Dental	Class 2	872.3770	2008-07-09
HOY	Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)	Ophthalmic	Class 1	886.4750	1978-03-31
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2015-04-20

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
K894358	Ormco Corp.	LUMINA ORTHODONTIC BRACKET	1989-09-15
K925012	American Orthodontics	PLASTIC CHAIN	1993-09-13
K881936	Iberhospitex, S.A.	OPER-FILM-ADHESIVE MEMBRANE	1988-08-31
K150256	Argentum Medical	SILVERLON BURN CONTACT DRESSINGS	2015-04-30
K112640	Ormco Corp.	HYPERELASTIC WIRE	2011-11-16

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0038-2025	3M Company Health Care Business 3m Center	U	3M Tegaderm CHG, Chlorhexidine Gluconate I.V. Securement Dressing, REF 1658R
Z-0013-2019	COVIDIEN LLC	1	Kerlix AMD Antimicrobial Bandage Roll, 6 Ply, 4-1/2 x 12.3 (11.4 cm x 3.7m), REF 3332 Product Usage- as both primary and secondary dressing containing PHMB (polyhexamethylene biguanide) to resist bacterial colonization within the dressing and bacterial penetration through the dressing.
Z-0014-2019	COVIDIEN LLC	1	Kerlix Bandage Roll, 100% Cotton, 6 Ply, Large 4-1/2 x 4-1/8 yd (11.4 cm x 3.7m), REF 6715 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.
Z-0015-2019	COVIDIEN LLC	1	Kerlix Gauze Roll, 6 Ply, Large 4-1/2 x 4-1/8 yd (11.4 cm x 3.7m) Stretched, REF 7880 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.
Z-0016-2019	COVIDIEN LLC	1	Kerlix Bandage Roll, 100 Cotton, 8 Ply, Large 4-1/2 x 9.3 (11.4 cm x 2.8 m), REF 6716 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.

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2411056	BUFFALO DENTAL MFG. CO., INC.	SYOSSET, NY, US
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3032911850. Last updated year: 2026. Please use registration number 3032911850 when referencing this establishment in official correspondence.