Dental Device Guide
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Manufacturer registered with FDA

Tecnofar S.p.A

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

FDA owner/operator10082256Manufacturer
Device types listed
1
Brands and models
0
510(k) clearances
0as applicant
Markets registered in
1010 registrations outside the US
Establishments
1Italy

Registered in 10 markets

Where regulators' registries name Tecnofar S.p.A as the manufacturer or the registration holder of a device.

All markets
United States: 1 device types listedSerbia: 2 registrationsBrazil: 1 registrationsCosta Rica: 1 registrationsEgypt: 1 registrationsEuropean Union: 1 registrationsIsrael: 1 registrationsPeru: 1 registrationsTaiwan: 1 registrationsUnited Kingdom: 1 registrations
RegisteredHome: ItalyOne marker per market
MarketRegulatorNamed asName on the registryRegistrationsIssuedRecords
United StatesFDAManufacturerTecnofar S.p.A1 device types—Below
SerbiaALIMSManufacturerTECNOFAR S.p.A.22023–2026Pure Global AI
BrazilANVISAManufacturerTECNOFAR S.P.A.12014–2014Pure Global AI
Costa RicaMinisterio de SaludManufacturerTecnofar S.p.A1—Pure Global AI
EgyptEDAManufacturerTecnofar S.P.A.,12026–2026Pure Global AI
European UnionEUDAMEDManufacturerTECNOFAR s.p.a.1—Pure Global AI
IsraelAMARManufacturerTecnofar s.p.a.1—Pure Global AI
PeruDIGEMIDManufacturerTECNOFAR s.p.a.12023–2023Pure Global AI
TaiwanTFDAManufacturerTECNOFAR S.p.A.12026–2026Pure Global AI
United KingdomMHRAManufacturerTecnofar s.p.a.1—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 Tecnofar S.p.A currently lists, by FDA device type, with the brand and model names on the listing.

Device typeCategoryRoleBrands and modelsListed since
Dental NeedleDZM · Class 1Dental needles & syringesMaker—2021

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
TECNOFAR S.P.A.FDA reg. 3004514268Delebio Sondrio, ItalyManufacturer

Sources

FDA establishment registration & device listing (search FDA, owner/operator 10082256). 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.