Manufacturer registered with FDA

Medency Srl

Vicenza, Italy. Lists 1 dental device type with FDA across 1 registered establishment.

FDA owner/operator10089308Contract manufacturer
Device types listed
1
Brands and models
1
510(k) clearances
0as applicant
Markets registered in
821 registrations outside the US
Establishments
1Italy

Registered in 8 markets

Where regulators' registries name Medency Srl as the manufacturer or the registration holder of a device.

All markets
United States: 1 device types listedEuropean Union: 9 registrationsCosta Rica: 4 registrationsAustralia: 2 registrationsPeru: 2 registrationsSaudi Arabia: 2 registrationsIsrael: 1 registrationsUnited Kingdom: 1 registrations
RegisteredHome: ItalyOne marker per market
MarketRegulatorNamed asName on the registryRegistrationsIssuedRecords
United StatesFDAManufacturerMedency Srl1 device types—Below
European UnionEUDAMEDRegistration holderMedency S.r.l.Medency Srl9—Pure Global AI
Costa RicaMinisterio de SaludManufacturerMEDENCY SRL4—Pure Global AI
AustraliaTGAManufacturerMedency Srl22025–2026Pure Global AI
PeruDIGEMIDManufacturerMEDENCY S.r.l..22021–2025Pure Global AI
Saudi ArabiaSFDAManufacturerMedency Srl2—Pure Global AI
IsraelAMARManufacturerMedency Srl1—Pure Global AI
United KingdomMHRAManufacturerMedency Srl1—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 Medency Srl currently lists, by FDA device type, with the brand and model names on the listing.

Device typeCategoryRoleBrands and modelsListed since
Laser Activator for PolymerizationQNF · Class 2—Maker
Fibercure
2024

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
MEDENCY SRLFDA reg. 3030090167Vicenza Veneto, ItalyContract manufacturer

Sources

FDA establishment registration & device listing (search FDA, owner/operator 10089308). 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.