Manufacturer registered with FDA

BEGO Implant Systems GmbH & Co. KG

Bremen, Germany. Lists 4 dental device types with FDA across 1 registered establishment, and holds 2 510(k) clearances as applicant.

FDA owner/operator10028893Manufacturer
Device types listed
4
Brands and models
0
510(k) clearances
22009–2021
Markets registered in
10292 registrations outside the US
Establishments
1Germany
2009: 12021: 1200020102020

510(k) clearances per year, 2000–2026

Registered in 10 markets

Where regulators' registries name BEGO Implant Systems GmbH & Co. KG as the manufacturer or the registration holder of a device.

All markets
United States: 4 device types listedCanada: 130 registrationsSaudi Arabia: 98 registrationsUnited Kingdom: 26 registrationsTaiwan: 12 registrationsChina: 8 registrationsSouth Korea: 7 registrationsSerbia: 6 registrationsEuropean Union: 4 registrationsEgypt: 1 registrations
RegisteredHome: GermanyOne marker per market
MarketRegulatorNamed asName on the registryRegistrationsIssuedRecords
United StatesFDAManufacturerBEGO Implant Systems GmbH & Co. KG2 clearances2009–2021Below
CanadaHealth CanadaRegistration holderBEGO IMPLANT SYSTEMS GMBH & CO. KG1302001–2023Pure Global AI
Saudi ArabiaSFDAManufacturerBEGO Implant Systems GmbH & Co. KG98—Pure Global AI
United KingdomMHRAManufacturerBEGO Implant Systems GmbH & Co. KG26—Pure Global AI
TaiwanTFDAManufacturerBEGO IMPLANT SYSTEMS GMBH & CO. KGBEGO IMPLANT SYSTEMS GMBH & CO., KG122008–2018Pure Global AI
ChinaNMPARegistration holder德国贝格种植系统有限公司BEGO Implant Systems GmbH & Co. KG德国贝格种植系统有限公司BEGO Implant Systems GmbH & Co.KG · 德国贝格种植系统有限公司 BEGO Implant Systems GmbH & Co.KG · +18—Pure Global AI
South KoreaMFDSManufacturerBEGO Implant Systems GmbH & Co.KGBEGO Implant Systems GmbH & Co. KG · BEGO Implant Systems GmbH&Co.KG72007–2007Pure Global AI
SerbiaALIMSManufacturerBEGO Implant Systems GmbH & Co. KG62024–2025Pure Global AI
European UnionEUDAMEDManufacturerBEGO Implant Systems GmbH & Co. KG4—Pure Global AI
EgyptEDAManufacturerBEGO Implant Systems GmbH & Co. KG,12025–2025Pure 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 BEGO Implant Systems GmbH & Co. KG currently lists, by FDA device type, with the brand and model names on the listing.

Device typeCategoryRoleBrands and modelsListed since
Root-Form Endosseous ImplantDZE · Class 2Dental implantsMaker—2021
Preformed Impression TrayEHY · Class 1Impression traysMaker—2017
Endosseous Dental Implant AccessoriesNDP · Class 1Implant instruments & surgical kitsMaker—2017
Endosseous Dental Implant AbutmentNHA · Class 2Implant abutmentsMaker—2021

Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026

510(k) clearances

Clearances on which FDA names BEGO Implant Systems GmbH & Co. KG as the applicant.

Decided510(k)DeviceDevice type
13 Jan 2021K201700BEGO Semados® RS/RSX Implant SystemDZE Root-Form Endosseous Implant
6 Oct 2009K090716BEGO SEMADOS S-LINEDZE Root-Form Endosseous Implant

Registered establishments

EstablishmentLocationWhat it does
BEGO IMPLANT SYSTEMS GMBH & CO. KGFDA reg. 3008252251Bremen, GermanyManufacturer

Sources

FDA establishment registration & device listing (search FDA, owner/operator 10028893). 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.