Dental Device Guide
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Manufacturer registered with FDA

DEWIMED Medizintechnik GmbH

Tuttlingen, Germany. Lists 15 dental device types with FDA across 1 registered establishment.

FDA owner/operator9030270Manufacturer
Device types listed
15
Brands and models
0
510(k) clearances
0as applicant
Markets registered in
10986 registrations outside the US
Establishments
1Germany

Registered in 10 markets

Where regulators' registries name DEWIMED Medizintechnik GmbH as the manufacturer or the registration holder of a device.

All markets
United States: 15 device types listedThailand: 848 registrationsSouth Korea: 110 registrationsColombia: 16 registrationsEuropean Union: 5 registrationsIsrael: 2 registrationsPeru: 2 registrationsAustralia: 1 registrationsCosta Rica: 1 registrationsTaiwan: 1 registrations
RegisteredHome: GermanyOne marker per market
MarketRegulatorNamed asName on the registryRegistrationsIssuedRecords
United StatesFDAManufacturerDEWIMED Medizintechnik GmbH15 device types—Below
ThailandThai FDAManufacturerDEWIMED MEDIZINTECHNIK GMBH848—Pure Global AI
South KoreaMFDSManufacturerDEWIMED Medizintechnik GmbHDEWIMED Medizintechnik GmbH.1101999–2025Pure Global AI
ColombiaINVIMARegistration holderDEWIMED MEDIZINTECHNIK GMBH16—Pure Global AI
European UnionEUDAMEDManufacturerDEWIMED Medizintechnik GmbH5—Pure Global AI
IsraelAMARManufacturerDEWIMED Medizintechnik GmbHDEWIMED Medizintechnik Gmbh2—Pure Global AI
PeruDIGEMIDManufacturerDEWIMED MEDIZINTECHNIK GmbH22012–2012Pure Global AI
AustraliaTGAManufacturerDewimed medizintechnik GmbH12006–2006Pure Global AI
Costa RicaMinisterio de SaludManufacturerDEWIMED MEDIZINTECHNIK GMBH1—Pure Global AI
TaiwanTFDAManufacturerDEWIMED MEDIZINTECHNIK GMBH12014–2014Pure 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 DEWIMED Medizintechnik GmbH currently lists, by FDA device type, with the brand and model names on the listing.

Device typeCategoryRoleBrands and modelsListed since
Orthodontic Screw Expansion RetainerDYJ · Class 1Retainers, expanders & headgearMaker—2012
Mouth MirrorEAX · Class 1Dental hand instrumentsMaker—2014
Suction Operatory UnitEBR · Class 1Suction & evacuation unitsMaker—2014
Air and/or Water Syringe UnitECB · Class 1Dental hand instrumentsMaker—2014
Dental Surgical Tissue ScissorsEGN · Class 1Dental hand instrumentsMaker—1997
Periodontic ProbeEIX · Class 1Dental hand instrumentsMaker—2014
Surgical HemostatEMD · Class 1Dental hand instrumentsMaker—1997
Surgical Biopsy PunchEME · Class 1Dental hand instrumentsMaker—1997
Surgical Tooth Extractor ForcepsEMG · Class 1Dental hand instrumentsMaker—2014
Surgical Rongeur ForcepsEMH · Class 1Dental hand instrumentsMaker—1997
Surgical Bone FileEMI · Class 1Dental hand instrumentsMaker—1997
Dental Surgical ElevatorEMJ · Class 1Dental hand instrumentsMaker—2014
Dental Surgical CuretteEMK · Class 1Dental hand instrumentsMaker—1997
Surgical Bone ChiselEML · Class 1Dental hand instrumentsMaker—1997
Surgical Osteotome ChiselEMM · Class 1Dental hand instrumentsMaker—1997

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
DEWIMED MEDIZINTECHNIK GMBHFDA reg. 3000286616TUTTLINGEN Baden-Wurttemberg, GermanyManufacturer

Sources

FDA establishment registration & device listing (search FDA, owner/operator 9030270). 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.