Dental Device Guide
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Manufacturer registered with FDA

Nical Spa

MILAN (MI), Italy. Lists 1 dental device type with FDA across 1 registered establishment, and holds 1 510(k) clearance as applicant.

FDA owner/operator9019546Manufacturer
Device types listed
1
Brands and models
1
510(k) clearances
12015–2015
Markets registered in
56 registrations outside the US
Establishments
1Italy
2015: 120102020

510(k) clearances per year, 2007–2026

Registered in 5 markets

Where regulators' registries name Nical Spa as the manufacturer or the registration holder of a device.

All markets
United States: 1 device types listedTaiwan: 2 registrationsUnited Kingdom: 2 registrationsAustralia: 1 registrationsIsrael: 1 registrations
RegisteredHome: ItalyOne marker per market
MarketRegulatorNamed asName on the registryRegistrationsIssuedRecords
United StatesFDAManufacturerNical Spa1 clearances2015–2015Below
TaiwanTFDAManufacturerNICAL SPA22016–2021Pure Global AI
United KingdomMHRAManufacturerNical SRL2—Pure Global AI
AustraliaTGAManufacturerNical SRL12025–2025Pure Global AI
IsraelAMARManufacturerNICAL SPA1—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 Nical Spa currently lists, by FDA device type, with the brand and model names on the listing.

Device typeCategoryRoleBrands and modelsListed since
Digital Extraoral Source X-Ray SystemMUH · Class 2Dental X-ray unitsMaker
NICAL SMART MICRO, NSM1001AA,NPR1000AA, NPR1000VE.
2015

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 Nical Spa as the applicant.

Decided510(k)DeviceDevice type
18 Mar 2015K143703NICAL SMART MICRO CR system for intraoral dental imagesMUH Digital Extraoral Source X-Ray System

Registered establishments

EstablishmentLocationWhat it does
NICAL SPAFDA reg. 3003314115MILAN (MI) Lombardy, ItalyManufacturer

Sources

FDA establishment registration & device listing (search FDA, owner/operator 9019546). 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.