Dental Device Guide
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Not currently registered with FDA under this name

3M Espe Dental Products

Bavaria D-82228 Seefeld, Germany. Named as applicant on 12 dental 510(k) clearances between 2006 and 2023. No establishment is registered with FDA under this exact name today.

2 clearances in five years
Device types listed
0
Brands and models
0
510(k) clearances
122006–2023
Markets registered in
11530 registrations outside the US
Establishments
0—
2006: 12007: 12008: 12010: 12011: 22012: 12014: 12019: 22023: 2200020102020

510(k) clearances per year, 2000–2026

Registered in 11 markets

Where regulators' registries name 3M Espe Dental Products as the manufacturer or the registration holder of a device.

All markets
United States: 12 clearancesCanada: 195 registrationsSaudi Arabia: 96 registrationsCosta Rica: 85 registrationsSouth Korea: 72 registrationsSerbia: 31 registrationsUnited Kingdom: 24 registrationsAustralia: 22 registrationsHong Kong: 3 registrationsBrazil: 1 registrationsIsrael: 1 registrations
RegisteredHome: GermanyOne marker per market
MarketRegulatorNamed asName on the registryRegistrationsIssuedRecords
United StatesFDAApplicant3M Espe Dental Products12 clearances2006–2023Below
CanadaHealth CanadaRegistration holder3M ESPE DENTAL PRODUCTS1951999–2021Pure Global AI
Saudi ArabiaSFDAManufacturer3M ESPE Dental Products96—Pure Global AI
Costa RicaMinisterio de SaludManufacturer3M ESPE Dental Products3M ESPE DENTAL PRODUCTS · 3M ESPE DENTAL PRODUCTS.85—Pure Global AI
South KoreaMFDSManufacturer3M ESPE Dental Products721998–2026Pure Global AI
SerbiaALIMSManufacturer3M ESPE Dental Products312022–2025Pure Global AI
United KingdomMHRAManufacturer3M ESPE Dental Products24—Pure Global AI
AustraliaTGAManufacturer3M ESPE Dental Products222004–2024Pure Global AI
Hong KongMDDManufacturer3M ESPE Dental Products32026–2026Pure Global AI
BrazilANVISAManufacturer3 M ESPE DENTAL PRODUCTS12010–2010Pure Global AI
IsraelAMARManufacturer3M ESPE Dental products1—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 Espe Dental Products as the applicant.

Decided510(k)DeviceDevice type
10 May 2023K2313383M™ Clinpro™ Clear 2.1% Sodium Fluoride TreatmentLBH Cavity Varnish
6 Feb 2023K2302703M™ VitCal Liner/BaseEJK Calcium Hydroxide Cavity Liner
29 May 2019K1911223M RelyX Pediatric Resin Modified Glass Ionomer CementEMA Dental Cement
2 Jan 2019K1834763M Filtek Universal RestorativeEBF Resin Tooth Shade Material
8 May 2014K141081FILTEK BULK FILL POSTERIOR RESTROATIVEEBF Resin Tooth Shade Material
19 Mar 2012K120453FILTEK BULK FILL FLOWABLE RESTORATIVEEBF Resin Tooth Shade Material
5 May 2011K111185RELYX LUTING PLUS AUTOMIXEMA Dental Cement
21 Jan 2011K110131LAVA ULTIMATE CAD/CAM RESTORATIVE FOR CEREC / E4D, LAVA ULTIMATE IMPLANT CROWN RESTORATIVEEBF Resin Tooth Shade Material
10 Mar 2010K092141VANISH VARNISH, 5% SODIUM FLUORIDE WHITE VARNISHLBH Cavity Varnish
17 Jan 2008K073395GILB-2, GLASS IONOMER PROTECTIVE COATINGEMA Dental Cement
22 May 2007K070956SEA2 SELF ETCH ADHESIVEKLE Resin Tooth Bonding Agent
25 Oct 2006K062292UNICEMEMA Dental Cement

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

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.