Dental Device Guide
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Manufacturer registered with FDA

Devemed GmbH

NEUHAUSEN OB ECK, Germany. Lists 38 dental device types with FDA across 1 registered establishment.

FDA owner/operator9083619Contract manufacturerManufacturer
Device types listed
38
Brands and models
0
510(k) clearances
0as applicant
Markets registered in
8221 registrations outside the US
Establishments
1Germany

Registered in 8 markets

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

All markets
United States: 38 device types listedEuropean Union: 129 registrationsSerbia: 46 registrationsSouth Korea: 23 registrationsAustralia: 8 registrationsTaiwan: 7 registrationsBrazil: 5 registrationsIsrael: 3 registrations
RegisteredHome: GermanyOne marker per market
MarketRegulatorNamed asName on the registryRegistrationsIssuedRecords
United StatesFDAManufacturerDevemed GmbH38 device types—Below
European UnionEUDAMEDManufacturerdevemed GmbH129—Pure Global AI
SerbiaALIMSManufacturerdevemed GmbH462024–2025Pure Global AI
South KoreaMFDSManufacturerdevemed GmbH232001–2019Pure Global AI
AustraliaTGAManufacturerDevemed GmbH82021–2024Pure Global AI
TaiwanTFDAManufacturerDEVEMED GMBH72009–2022Pure Global AI
BrazilANVISAManufacturerDEVEMED GMBH52015–2015Pure Global AI
IsraelAMARManufacturerDevemed GmbHDevemed Gmbh · devemed GmbH3—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 Devemed GmbH currently lists, by FDA device type, with the brand and model names on the listing.

Device typeCategoryRoleBrands and modelsListed since
Dental Hand InstrumentsDZN · Class 1Dental hand instrumentsMaker—2020
Mouth MirrorEAX · Class 1Dental hand instrumentsMaker—2007
Air and/or Water Syringe UnitECB · Class 1Dental hand instrumentsMaker—2007
Orthodontic Band PusherECS · Class 1Dental hand instrumentsMaker—2006
Articulation Paper ForcepsEFK · Class 1Dental hand instrumentsMaker—2020
Dental Dressing ForcepsEFL · Class 1Dental hand instrumentsMaker—2006
Dental Surgical Tissue ScissorsEGN · Class 1Dental hand instrumentsMaker—2007
Preformed Impression TrayEHY · Class 1Impression traysMaker—2007
All Types RetractorEIG · Class 1Dental hand instrumentsMaker—2006
Dental Instrument Depth GaugeEIL · Class 1Dental hand instrumentsMaker—2007
Crown RemoverEIS · Class 1Dental hand instrumentsMaker—2007
Periodontic ProbeEIX · Class 1Dental hand instrumentsMaker—2006
Dental Plastic Filling InstrumentEIY · Class 1Dental hand instrumentsMaker—2006
Dental Instrument HandleEJB · Class 1Dental hand instrumentsMaker—2006
Rubber Dam FrameEJE · Class 1Rubber dam systemsMaker—2020
Rubber Dam Clamp ForcepsEJG · Class 1Rubber dam systemsMaker—2007
Dental BurEJL · Class 1Dental burs & diamondsMaker—2007
Operative ExplorerEKB · Class 1Dental hand instrumentsMaker—2006
Operative Dental ExcavatorEKC · Class 1Dental hand instrumentsMaker—2007
Operative Cutting InstrumentEKD · Class 1Dental hand instrumentsMaker—2020
Operative Dental Amalgam CarverEKH · Class 1Dental hand instrumentsMaker—2006
Operative Amalgam CarrierEKI · Class 1Dental hand instrumentsMaker—2020
Endodontic Root Canal PluggerEKR · Class 1Dental hand instrumentsMaker—2020
Endodontic CuretteEKT · Class 1Dental hand instrumentsMaker—2020
Surgical HemostatEMD · Class 1Dental hand instrumentsMaker—2020
Surgical Tooth Extractor ForcepsEMG · Class 1Dental hand instrumentsMaker—2006
Surgical Rongeur ForcepsEMH · Class 1Dental hand instrumentsMaker—2006
Surgical Bone FileEMI · Class 1Dental hand instrumentsMaker—2006
Dental Surgical ElevatorEMJ · Class 1Dental hand instrumentsMaker—2006
Dental Surgical CuretteEMK · Class 1Dental hand instrumentsMaker—2006
Surgical Bone ChiselEML · Class 1Dental hand instrumentsMaker—2006
Surgical Osteotome ChiselEMM · Class 1Dental hand instrumentsMaker—2006
Periodontic ScalerEMN · Class 1Dental hand instrumentsMaker—2006
Periodontic FileEMR · Class 1Dental hand instrumentsMaker—2007
Periodontic CuretteEMS · Class 1Dental hand instrumentsMaker—2020
Matrix RetainerJEP · Class 1Dental hand instrumentsMaker—2020
Orthodontic PlierJEX · Class 1Dental hand instrumentsMaker—2006
Endosseous Dental Implant AccessoriesNDP · Class 1Implant instruments & surgical kitsMaker—2007

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
DEVEMED GMBHFDA reg. 3005621335NEUHAUSEN OB ECK Baden-Wurttemberg, GermanyContract manufacturer, Manufacturer

Sources

FDA establishment registration & device listing (search FDA, owner/operator 9083619). 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.