Dental Device Guide
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Manufacturer registered with FDA

Richard Wolf GmbH

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

FDA owner/operator8010049Manufacturer
Device types listed
1
Brands and models
0
510(k) clearances
0as applicant
Markets registered in
196,212 registrations outside the US
Establishments
1Germany

Registered in 19 markets

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

All markets
United States: 1 device types listedThailand: 2,000 registrationsEuropean Union: 1,233 registrationsCanada: 625 registrationsSouth Korea: 586 registrationsUnited Kingdom: 547 registrationsSerbia: 247 registrationsBrazil: 244 registrationsSaudi Arabia: 228 registrationsTaiwan: 114 registrationsAustralia: 100 registrationsPeru: 75 registrationsChina: 69 registrationsCosta Rica: 58 registrationsJapan: 36 registrationsHong Kong: 18 registrationsIsrael: 12 registrationsColombia: 10 registrationsEgypt: 10 registrations
RegisteredHome: GermanyOne marker per market
MarketRegulatorNamed asName on the registryRegistrationsIssuedRecords
United StatesFDAManufacturerRichard Wolf GmbH1 device types—Below
ThailandThai FDAManufacturerRICHARD WOLF GMBH2,000—Pure Global AI
European UnionEUDAMEDRegistration holderRichard Wolf GmbH1,233—Pure Global AI
CanadaHealth CanadaRegistration holderRICHARD WOLF GMBH6251999–2026Pure Global AI
South KoreaMFDSManufacturerRichard Wolf GmbHRichard Wolf GmbH. · RICHARD WOLF GmbH · +25861999–2026Pure Global AI
United KingdomMHRAManufacturerRichard Wolf GmbH547—Pure Global AI
SerbiaALIMSManufacturerRichard Wolf GmbH2472021–2026Pure Global AI
BrazilANVISAManufacturerRICHARD WOLF GMBHRichard Wolf2442006–2026Pure Global AI
Saudi ArabiaSFDAManufacturerRichard Wolf GmbH228—Pure Global AI
TaiwanTFDAManufacturerRICHARD WOLF GMBHRichard Wolf GmbH1141981–2026Pure Global AI
AustraliaTGAManufacturerRichard Wolf GmbH1002005–2026Pure Global AI
PeruDIGEMIDManufacturerRICHARD WOLF GmbHRICHARD WOLF GMBH752014–2026Pure Global AI
ChinaNMPARegistration holder理查德沃尔夫有限责任公司Richard Wolf GmbH理查德沃尔夫有限责任公司Richard WolF GmbH · 理查德沃尔夫有限责任公司 Richard Wolf GmbH69—Pure Global AI
Costa RicaMinisterio de SaludManufacturerRichard Wolf GmbH58—Pure Global AI
JapanPMDARegistration holderＲｉｃｈａｒｄ　Ｗｏｌｆ　ＧｍｂＨ362008–2025Pure Global AI
Hong KongMDDManufacturerRichard Wolf GmbHRICHARD WOLF GMBH · RICHARD WOLF GmbH · +1182011–2026Pure Global AI
IsraelAMARManufacturerRichard Wolf GmbHRICHARD WOLF GMBH12—Pure Global AI
ColombiaINVIMAManufacturerRICHARD WOLF GMBHRICHARD WOLF10—Pure Global AI
EgyptEDAManufacturerRICHARD WOLF Gmbh,RICHARD WOLF GmbH, · Richard Wolf GmbH,102025–2026Pure 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 Richard Wolf GmbH currently lists, by FDA device type, with the brand and model names on the listing.

Device typeCategoryRoleBrands and modelsListed since
All Types RetractorEIG · Class 1Dental hand instrumentsMaker—1998

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
RICHARD WOLF GMBHFDA reg. 9611102KNITTLINGEN Baden-Wurttemberg, GermanyManufacturer

Sources

FDA establishment registration & device listing (search FDA, owner/operator 8010049). 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.