Manufacturer registered with FDA

Muller India Private Limited

GURGAON, India. Lists 1 dental device type with FDA across 1 registered establishment.

FDA owner/operator10085623Manufacturer
Device types listed
1
Brands and models
1
510(k) clearances
0as applicant
Markets registered in
55 registrations outside the US
Establishments
1India

Registered in 5 markets

Where regulators' registries name Muller India Private Limited as the manufacturer or the registration holder of a device.

All markets
United States: 1 device types listedIndia: 2 registrationsPeru: 1 registrationsTaiwan: 1 registrationsTanzania: 1 registrations
RegisteredHome: IndiaOne marker per market
MarketRegulatorNamed asName on the registryRegistrationsIssuedRecords
United StatesFDAManufacturerMuller India Private Limited1 device types—Below
IndiaCDSCORegistration holderMuller India Private Limited22023–2023Pure Global AI
PeruDIGEMIDManufacturerMULLER INDIA PVT. LTD12023–2023Pure Global AI
TaiwanTFDAManufacturerMULLER INDIA PRIVATE LIMITED12026–2026Pure Global AI
TanzaniaTMDAManufacturerMuller India Private Limited12025–2025Pure 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 Muller India Private Limited currently lists, by FDA device type, with the brand and model names on the listing.

Device typeCategoryRoleBrands and modelsListed since
Dental BurEJL · Class 1Dental burs & diamondsMaker
PreciDent
2022

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
MULLER INDIA PRIVATE LIMITEDFDA reg. 3023339159GURGAON Haryana, IndiaManufacturer

Sources

FDA establishment registration & device listing (search FDA, owner/operator 10085623). 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.