Manufacturer registered with FDA

Worldwork S.R.L

MONTEBELLO VICENTINO, Italy. Lists 4 dental device types with FDA across 1 registered establishment, and holds 1 510(k) clearance as applicant.

FDA owner/operator9090471Manufacturer1 clearance in five years
Device types listed
4
Brands and models
4
510(k) clearances
12023–2023
Markets registered in
1031 registrations outside the US
Establishments
1Italy
2023: 120102020

510(k) clearances per year, 2007–2026

Registered in 10 markets

Where regulators' registries name Worldwork S.R.L as the manufacturer or the registration holder of a device.

All markets
United States: 4 device types listedTaiwan: 11 registrationsSouth Korea: 7 registrationsAustralia: 3 registrationsIsrael: 3 registrationsBrazil: 2 registrationsHong Kong: 2 registrationsCosta Rica: 1 registrationsEuropean Union: 1 registrationsSerbia: 1 registrations
RegisteredHome: ItalyOne marker per market
MarketRegulatorNamed asName on the registryRegistrationsIssuedRecords
United StatesFDAManufacturerWorldwork S.R.L1 clearances2023–2023Below
TaiwanTFDAManufacturerWORLD WORK S.R.L.WORLD WORK SRL112006–2025Pure Global AI
South KoreaMFDSManufacturerWORLD WORK S.R.L.WORLD WORK S.r.l. · WORLD ? WORK srl · +272006–2017Pure Global AI
AustraliaTGAManufacturerWorld Work SRL32009–2024Pure Global AI
IsraelAMARManufacturerWorld Work SRL3—Pure Global AI
BrazilANVISAManufacturerWORLD WORK SRL22013–2023Pure Global AI
Hong KongMDDManufacturerWORLD WORK SRLWorld Work S.R.L.22008–2025Pure Global AI
Costa RicaMinisterio de SaludManufacturerWORLD WORK SRL1—Pure Global AI
European UnionEUDAMEDManufacturerWORLD WORK SRL1—Pure Global AI
SerbiaALIMSManufacturerWORLD WORK SRL12023–2023Pure 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 Worldwork S.R.L currently lists, by FDA device type, with the brand and model names on the listing.

Device typeCategoryRoleBrands and modelsListed since
Saliva Ejector MouthpieceDYN · Class 1—Maker
Mouthpiece, saliva ejector
2006
Amalgam Dental CapsuleDZS · Class 1—Maker
CAPSULES, DENTAL AMALGAM
2012
Amalgam AlloyEJJ · Class 2—Maker
ALLOY, AMALGAM DENTAL AMALGAM
2023
Dental AmalgamOIV · Class 2—Maker
ALLOY, AMALGAM DENTAL AMALGAM
2023

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 Worldwork S.R.L as the applicant.

Decided510(k)DeviceDevice type
1 May 2023K223182Arial Dental, Mistral Dental Amalgam, World Work Dental Amalgam, BMS Non Gamma 2 Alloy, Flexi Alloy, Hi-S Alloy, WW Dental Amalgam, Hi - Mix, Non Gamma 2 AlloyOIV Dental Amalgam

Registered establishments

EstablishmentLocationWhat it does
WORLD WORK SRLFDA reg. 3006153346MONTEBELLO VICENTINO Vicenza, ItalyManufacturer

Sources

FDA establishment registration & device listing (search FDA, owner/operator 9090471). 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.