Registered with FDA

Rudolf Riester GmbH & Co KG

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

FDA owner/operator8010492Repacker / relabeler
Device types listed
1
Brands and models
1
510(k) clearances
0as applicant
Markets registered in
16747 registrations outside the US
Establishments
1Germany

Registered in 16 markets

Where regulators' registries name Rudolf Riester GmbH & Co KG as the manufacturer or the registration holder of a device.

All markets
United States: 1 device types listedColombia: 295 registrationsSaudi Arabia: 100 registrationsSouth Korea: 91 registrationsCanada: 61 registrationsUnited Kingdom: 41 registrationsTaiwan: 37 registrationsCosta Rica: 29 registrationsPeru: 27 registrationsSerbia: 26 registrationsAustralia: 21 registrationsBrazil: 5 registrationsTanzania: 5 registrationsIsrael: 4 registrationsChina: 3 registrationsHong Kong: 2 registrations
RegisteredHome: GermanyOne marker per market
MarketRegulatorNamed asName on the registryRegistrationsIssuedRecords
United StatesFDAListerRudolf Riester GmbH & Co KG1 device types—Below
ColombiaINVIMARegistration holderRUDOLF RIESTER GMBHRUDOLF RIESTER GMBH & CO.KG295—Pure Global AI
Saudi ArabiaSFDAManufacturerRUDOLF RIESTER GMBH100—Pure Global AI
South KoreaMFDSManufacturerRudolf Riester GmbHRudolf Riester GmbH & Co. KG · Rudolf Riester Gmbh · +1912000–2025Pure Global AI
CanadaHealth CanadaRegistration holderRUDOLF RIESTER GMBH612010–2015Pure Global AI
United KingdomMHRAManufacturerRudolf Riester GmbH41—Pure Global AI
TaiwanTFDAManufacturerRUDOLF. RIESTER GMBH & CO. KGRUDOLF RIESTER GMBH · Rudolf Riester GmbH · +1371978–2022Pure Global AI
Costa RicaMinisterio de SaludManufacturerRudolf Riester GmbH29—Pure Global AI
PeruDIGEMIDManufacturerRUDOLF RIESTER GmbHRUDOLF RIESTER GMBH272008–2026Pure Global AI
SerbiaALIMSManufacturerRudolf Riester GmbH262022–2026Pure Global AI
AustraliaTGAManufacturerRudolf Riester GmbH & Co KGRudolf Riester GmbH212008–2020Pure Global AI
BrazilANVISAManufacturerRUDOLF RIESTER GMBH & CO. KG.RUDOLF RIESTER GMBH & CO. KG52007–2025Pure Global AI
TanzaniaTMDAManufacturerRudolf Riester GmbH52022–2023Pure Global AI
IsraelAMARManufacturerRudolf Riester GmbH4—Pure Global AI
ChinaNMPARegistration holder里斯特鲁道夫有限责任公司Rudolf Riester GmbH3—Pure Global AI
Hong KongMDDManufacturerRudolf Riester Gmbh22023–2023Pure 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 Rudolf Riester GmbH & Co KG currently lists, by FDA device type, with the brand and model names on the listing.

Device typeCategoryRoleBrands and modelsListed since
Surgical Headlight LightEBA · Class 1Dental operating lightsLister
K-L.E.D Surgical Headlight
2010

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
RUDOLF RIESTER GMBHFDA reg. 8010482JUNGINGEN Baden-Wurttemberg, GermanyRepacker / relabeler

Other names on FDA records

Rudolf Riester GmbH

Sources

FDA establishment registration & device listing (search FDA, owner/operator 8010492). 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.