Manufacturer registered with FDA

Benchmark Electronics, Inc

Winona, MN, United States. Lists 1 dental device type with FDA across 1 registered establishment.

FDA owner/operator9026315Contract manufacturer
Device types listed
1
Brands and models
0
510(k) clearances
0as applicant
Markets registered in
564 registrations outside the US
Establishments
1United States

Registered in 5 markets

Where regulators' registries name Benchmark Electronics, Inc as the manufacturer or the registration holder of a device.

All markets
United States: 1 device types listedCosta Rica: 17 registrationsSouth Korea: 17 registrationsTaiwan: 16 registrationsColombia: 14 registrations
RegisteredHome: United StatesOne marker per market
MarketRegulatorNamed asName on the registryRegistrationsIssuedRecords
United StatesFDAManufacturerBenchmark Electronics, Inc1 device types—Below
Costa RicaMinisterio de SaludManufacturerBenchmark Electronics, IncBenchmark Electronics, Inc.17—Pure Global AI
South KoreaMFDSManufacturerBenchmark Electronics Inc.Benchmark Electronics, Inc · Benchmark Electronics Inc172009–2020Pure Global AI
TaiwanTFDAManufacturerBENCHMARK ELECTRONICS INC.162004–2023Pure Global AI
ColombiaINVIMAManufacturerBENCHMARK ELECTRONICS, INC.BENCHMARK ELECTRONICS INC · BENCHMARK ELECTRONICS, INC14—Pure 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 Benchmark Electronics, Inc currently lists, by FDA device type, with the brand and model names on the listing.

Device typeCategoryRoleBrands and modelsListed since
Operative Dental UnitEIA · Class 1Dental chairs & operative unitsMaker—2026

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
BENCHMARK ELECTRONICS, INC.FDA reg. 2133786ROCHESTER, MN, United StatesContract manufacturer

Sources

FDA establishment registration & device listing (search FDA, owner/operator 9026315). 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.