Not currently registered with FDA under this name

3M Deutschland GmbH

Seefeld, Germany. Named as applicant on 12 dental 510(k) clearances between 2012 and 2022. No establishment is registered with FDA under this exact name today.

1 clearance in five years
Device types listed
0
Brands and models
0
510(k) clearances
122012–2022
Markets registered in
7442 registrations outside the US
Establishments
0—
2012: 12013: 12014: 22015: 12016: 32017: 12019: 22022: 120102020

510(k) clearances per year, 2007–2026

Registered in 7 markets

Where regulators' registries name 3M Deutschland GmbH as the manufacturer or the registration holder of a device.

All markets
United States: 12 clearancesColombia: 268 registrationsTaiwan: 78 registrationsIsrael: 47 registrationsBrazil: 26 registrationsPeru: 22 registrationsEuropean Union: 1 registrations
RegisteredHome: GermanyOne marker per market
MarketRegulatorNamed asName on the registryRegistrationsIssuedRecords
United StatesFDAApplicant3M Deutschland GmbH12 clearances2012–2022Below
ColombiaINVIMAManufacturer3M DEUTSCHLAND GMBH268—Pure Global AI
TaiwanTFDAManufacturer3M Deutschland GmbH3M DEUTSCHLAND GMBH · 3M DEUTSCHLAND GMBH.782004–2026Pure Global AI
IsraelAMARManufacturer3M Deutschland GmbH3M Deutschland GmBH · 3M- deutschland47—Pure Global AI
BrazilANVISAManufacturer3M DEUTSCHLAND GMBH262001–2021Pure Global AI
PeruDIGEMIDManufacturer3M DEUTSCHLAND GmbH3M DEUTSCHLAND GMBH222006–2026Pure Global AI
European UnionEUDAMEDRegistration holder3M Deutschland GmbH1—Pure Global AI

Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026

510(k) clearances

Clearances on which FDA names 3M Deutschland GmbH as the applicant.

Decided510(k)DeviceDevice type
1 Feb 2022K220257PermadyneELW Impression Material
5 Nov 2019K192992Suglue 3EMA Dental Cement
31 Oct 2019K192961ADH19KLE Resin Tooth Bonding Agent
31 Oct 2017K173318Rapid HB, Rapid LB, Rapid MBELW Impression Material
1 Sep 2016K161922XP202EIH Porcelain Powder
13 Apr 2016K153174Ketac Universal AplicapEMA Dental Cement
11 Mar 2016K151748Clean & MorePIP Airbrush Accessory Prophy Powder
14 Sep 2015K151144SuPro 100EBG Resin Temporary Crown and Bridge
24 Oct 2014K140684CLINPRO PROPHY POWDERPIP Airbrush Accessory Prophy Powder
7 Mar 2014K133436FLASH AR; FLASH AR QUICKELW Impression Material
30 May 2013K131404FLASH AR PENTA / FLASH AR PENTA QUICKELW Impression Material
2 May 2012K120438FLASH (DIFFERENT MATERIALS)ELW Impression Material

Some of these clearances are listed with FDA today by another company: Solventum US LLC (10), Jensen Industries, Inc. (1).

Sources

FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record of the most recent filing, which can be a US agent.