Dental Device Guide
Add your company

Registered with FDA

Elcon Medical Instruments GmbH

TUTTLINGEN, Germany. Lists 2 dental device types with FDA across 1 registered establishment.

FDA owner/operator9003951Repacker / relabeler
Device types listed
2
Brands and models
0
510(k) clearances
0as applicant
Markets registered in
137,851 registrations outside the US
Establishments
1Germany

Registered in 13 markets

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

All markets
United States: 2 device types listedThailand: 7,296 registrationsUnited Kingdom: 191 registrationsAustralia: 111 registrationsEuropean Union: 86 registrationsSerbia: 63 registrationsSouth Korea: 55 registrationsSaudi Arabia: 32 registrationsColombia: 8 registrationsBrazil: 3 registrationsTaiwan: 3 registrationsIsrael: 2 registrationsHong Kong: 1 registrations
RegisteredHome: GermanyOne marker per market
MarketRegulatorNamed asName on the registryRegistrationsIssuedRecords
United StatesFDAListerElcon Medical Instruments GmbH2 device types—Below
ThailandThai FDAManufacturerELCON MEDICAL INSTRUMENTS GMBHELCON Medical Instruments GmbH7,296—Pure Global AI
United KingdomMHRAManufacturerELCON Medical Instruments GmbH191—Pure Global AI
AustraliaTGAManufacturerElcon Medical Instruments GmbH1112018–2026Pure Global AI
European UnionEUDAMEDManufacturerELCON Medical Instruments GmbH86—Pure Global AI
SerbiaALIMSManufacturerELCON Medical Instruments GmbH632024–2025Pure Global AI
South KoreaMFDSManufacturerELCON Medical Instruments GmbH552003–2016Pure Global AI
Saudi ArabiaSFDAManufacturerELCON Medical Instruments GmbH32—Pure Global AI
ColombiaINVIMAManufacturerELCON MEDICAL INSTRUMENTS GMBH8—Pure Global AI
BrazilANVISAManufacturerELCON MEDICAL INSTRUMENTS GMBH32025–2025Pure Global AI
TaiwanTFDAManufacturerELCON MEDICAL INSTRUMENTS GMBH32008–2023Pure Global AI
IsraelAMARManufacturerELCON Medical Instruments GmbH2—Pure Global AI
Hong KongMDDManufacturerELCON Medical Instruments GmbH12025–2025Pure 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 Elcon Medical Instruments GmbH currently lists, by FDA device type, with the brand and model names on the listing.

Device typeCategoryRoleBrands and modelsListed since
Surgical Biopsy PunchEME · Class 1Dental hand instrumentsLister—1992
Surgical Rongeur ForcepsEMH · Class 1Dental hand instrumentsLister—1992

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
ELCON MEDICAL INSTRUMENTS GMBHFDA reg. 8043816TUTTLINGEN Baden-Wurttemberg, GermanyRepacker / relabeler

Sources

FDA establishment registration & device listing (search FDA, owner/operator 9003951). 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.