Manufacturer registered with FDA

Dpm USA Corp.

Sweetwater, FL, United States. Lists 2 dental device types with FDA across 1 registered establishment, and holds 2 510(k) clearances as applicant.

FDA owner/operator9008401Manufacturer
Device types listed
2
Brands and models
2
510(k) clearances
22009–2009
Markets registered in
4122 registrations outside the US
Establishments
1United States
2009: 2200020102020

510(k) clearances per year, 2000–2026

Registered in 4 markets

Where regulators' registries name Dpm USA Corp. as the manufacturer or the registration holder of a device.

All markets
United States: 2 device types listedColombia: 116 registrationsCosta Rica: 5 registrationsPeru: 1 registrations
RegisteredHome: United StatesOne marker per market
MarketRegulatorNamed asName on the registryRegistrationsIssuedRecords
United StatesFDAManufacturerDpm USA Corp.2 clearances2009–2009Below
ColombiaINVIMARegistration holderDPM USA CORP116—Pure Global AI
Costa RicaMinisterio de SaludManufacturerDPM USA CORPDPM USA CORP.5—Pure Global AI
PeruDIGEMIDManufacturerDPM USA CORP12017–2017Pure 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 Dpm USA Corp. currently lists, by FDA device type, with the brand and model names on the listing.

Device typeCategoryRoleBrands and modelsListed since
Intraoral Dental DrillDZA · Class 1Surgical drills & motorsMaker
Switch E
2016
Dental Belt and/or Gear Driven HandpieceEFA · Class 1Dental handpiecesMaker
Tubinetta Fit Lux, Tubinetta Ultra, Switch E, Bogotta Light Plus, Bogota Stilla Prime
2009

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 Dpm USA Corp. as the applicant.

Decided510(k)DeviceDevice type
27 Oct 2009K090055LOW & HIGH SPEED KITEFA Dental Belt and/or Gear Driven Handpiece
30 Jan 2009K083059AIR SONIC SCALERELC Ultrasonic Scaler

Registered establishments

EstablishmentLocationWhat it does
DPM USA CORP.FDA reg. 1063774Doral, FL, United StatesManufacturer

Sources

FDA establishment registration & device listing (search FDA, owner/operator 9008401). 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.