Manufacturer registered with FDA

Vitang Technology LLC

Irvine, CA, United States. Lists 2 dental device types with FDA across 1 registered establishment, and holds 1 510(k) clearance as applicant.

FDA owner/operator10060585ManufacturerRepacker / relabeler
Device types listed
2
Brands and models
2
510(k) clearances
12020–2020
Markets registered in
21 registrations outside the US
Establishments
1United States
2020: 120102020

510(k) clearances per year, 2007–2026

Registered in 2 markets

Where regulators' registries name Vitang Technology LLC as the manufacturer or the registration holder of a device.

All markets
United States: 2 device types listedIsrael: 1 registrations
RegisteredHome: United StatesOne marker per market
MarketRegulatorNamed asName on the registryRegistrationsIssuedRecords
United StatesFDAManufacturerVitang Technology LLC1 clearances2020–2020Below
IsraelAMARManufacturerVitang Technology, LLC1—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 Vitang Technology LLC currently lists, by FDA device type, with the brand and model names on the listing.

Device typeCategoryRoleBrands and modelsListed since
Dental Stain EraserMAU · Class 1—Lister
Teeth Whitening Pen
2019
Sequential AlignerNXC · Class 2Clear alignersMaker
Unismile Clear Aligner
2020

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 Vitang Technology LLC as the applicant.

Decided510(k)DeviceDevice type
29 Jan 2020K191837UniSmile Clear Aligner SystemNXC Sequential Aligner

Registered establishments

EstablishmentLocationWhat it does
VITANG TECHNOLOGY LLCFDA reg. 3015549533Irvine, CA, United StatesManufacturer, Repacker / relabeler

Sources

FDA establishment registration & device listing (search FDA, owner/operator 10060585). 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.