Dental Device Guide
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Not currently registered with FDA under this name

Makeo Healthcare Technologies Private Limited

Mumbai, India. Named as applicant on 1 dental 510(k) clearance between 2023 and 2023. No establishment is registered with FDA under this exact name today.

1 clearance in five years
Device types listed
0
Brands and models
0
510(k) clearances
12023–2023
Markets registered in
22 registrations outside the US
Establishments
0—
2023: 120102020

510(k) clearances per year, 2007–2026

Registered in 2 markets

Where regulators' registries name Makeo Healthcare Technologies Private Limited as the manufacturer or the registration holder of a device.

All markets
United States: 1 clearancesIndia: 2 registrations
RegisteredHome: IndiaOne marker per market
MarketRegulatorNamed asName on the registryRegistrationsIssuedRecords
United StatesFDAApplicantMakeo Healthcare Technologies Private Limited1 clearances2023–2023Below
IndiaCDSCORegistration holderMAKEO HEALTHCARE TECHNOLOGIES PRIVATE LIMITEDMakeO Healthcare Technologies Private Limited22023–2026Pure 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

510(k) clearances

Clearances on which FDA names Makeo Healthcare Technologies Private Limited as the applicant.

Decided510(k)DeviceDevice type
9 Feb 2023K223338Toothsi, SmilealignersNXC Sequential Aligner

Sources

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 of the most recent filing, which can be a US agent.