Dental Device Guide
Add your company

Manufacturer registered with FDA

RUDISCHHAUSER SURGICAL INSTRUMENTS MANUFACTURING GmbH

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

FDA owner/operator8010300Contract manufacturer
Device types listed
1
Brands and models
1
510(k) clearances
0as applicant
Markets registered in
5106 registrations outside the US
Establishments
1Germany

Registered in 5 markets

Where regulators' registries name RUDISCHHAUSER SURGICAL INSTRUMENTS MANUFACTURING GmbH as the manufacturer or the registration holder of a device.

All markets
United States: 1 device types listedThailand: 87 registrationsSouth Korea: 16 registrationsColombia: 2 registrationsTaiwan: 1 registrations
RegisteredHome: GermanyOne marker per market
MarketRegulatorNamed asName on the registryRegistrationsIssuedRecords
United StatesFDAManufacturerRUDISCHHAUSER SURGICAL INSTRUMENTS MANUFACTURING GmbH1 device types—Below
ThailandThai FDAManufacturerRUDISCHHAUSER SURGICAL INSTRUMENTS MANUFACTURING GMBH87—Pure Global AI
South KoreaMFDSManufacturerRudischhauser Surgical Instruments Manufacturing GmbHRUDISCHHAUSER SURGICAL INSTRUMENTS MANUFACTURING GMBH · RUDISCHHAUSER SURGICAL INSTRUMENTS MANUFACTURING GmbH · +1162010–2023Pure Global AI
ColombiaINVIMAManufacturerRUDISCHHAUSER SURGICAL INSTRUMENTS MANUFACTURING GMBH2—Pure Global AI
TaiwanTFDAManufacturerRUDISCHHAUSER SURGICAL INSTRUMENTS MANUFACTURING GMBH12016–2016Pure 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 RUDISCHHAUSER SURGICAL INSTRUMENTS MANUFACTURING GmbH currently lists, by FDA device type, with the brand and model names on the listing.

Device typeCategoryRoleBrands and modelsListed since
Surgical Osteotome ChiselEMM · Class 1Dental hand instrumentsMaker
IN1539
1984

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
RUDISCHHAUSER SURGICAL INSTRUMENTS MANUFACTURING GMBHFDA reg. 8010300TUTTLINGEN Baden-Wurttemberg, GermanyContract manufacturer

Sources

FDA establishment registration & device listing (search FDA, owner/operator 8010300). 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.