Dental Device Guide
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Manufacturer registered with FDA

Dent-A-Pharm Produktionsgesellschaft mbH

Barmstedt, Germany. Lists 1 dental device type with FDA across 1 registered establishment.

FDA owner/operator10039168Manufacturer
Device types listed
1
Brands and models
1
510(k) clearances
0as applicant
Markets registered in
7233 registrations outside the US
Establishments
1Germany

Registered in 7 markets

Where regulators' registries name Dent-A-Pharm Produktionsgesellschaft mbH as the manufacturer or the registration holder of a device.

All markets
United States: 1 device types listedEuropean Union: 196 registrationsSerbia: 22 registrationsSouth Korea: 8 registrationsPeru: 5 registrationsAustralia: 1 registrationsUnited Kingdom: 1 registrations
RegisteredHome: GermanyOne marker per market
MarketRegulatorNamed asName on the registryRegistrationsIssuedRecords
United StatesFDAManufacturerDent-A-Pharm Produktionsgesellschaft mbH1 device types—Below
European UnionEUDAMEDRegistration holderDent-A-Pharm Produktionsgesellschaft mbH196—Pure Global AI
SerbiaALIMSManufacturerdent a pharm Produktionsgesellschaft mbH222023–2026Pure Global AI
South KoreaMFDSManufacturerdent a pharm Produktionsgesellschaft mbHDent-A-Pharm Produktionsgesellschaft mbH82010–2026Pure Global AI
PeruDIGEMIDManufacturerDENT A PHARM PRODUKTIONSGESELLSCHAFT MBH52023–2025Pure Global AI
AustraliaTGAManufacturerdent a pharm Produktionsgesellschaft mbH12021–2021Pure Global AI
United KingdomMHRAManufacturerdent a pharm Produktionsgesellschaft mbH1—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

Devices listed with FDA

What Dent-A-Pharm Produktionsgesellschaft mbH currently lists, by FDA device type, with the brand and model names on the listing.

Device typeCategoryRoleBrands and modelsListed since
Resin Impression Tray MaterialEBH · Class 1Impression traysMaker
Light curing tray material
2011

Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026

Registered establishments

EstablishmentLocationWhat it does
DENT A PHARM PRODUKTIONSGESELLSCHAFT MBHFDA reg. 3009509745Barmstedt Schleswig-Holstein, GermanyManufacturer

Sources

FDA establishment registration & device listing (search FDA, owner/operator 10039168). 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.