Manufacturer registered with FDA

Dabur India Limited

NEW DELHI, India. Lists 2 dental device types with FDA across 1 registered establishment.

FDA owner/operator9058782ManufacturerRepacker / relabeler
Device types listed
2
Brands and models
9
510(k) clearances
0as applicant
Markets registered in
21 registrations outside the US
Establishments
1India

Registered in 2 markets

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

All markets
United States: 2 device types listedIndia: 1 registrations
RegisteredHome: IndiaOne marker per market
MarketRegulatorNamed asName on the registryRegistrationsIssuedRecords
United StatesFDAManufacturerDabur India Limited2 device types—Below
IndiaCDSCORegistration holderDabur India 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 Dabur India Limited currently lists, by FDA device type, with the brand and model names on the listing.

Device typeCategoryRoleBrands and modelsListed since
Manual ToothbrushEFW · Class 1ToothbrushesMaker
BEE SMARTDABURFRESHMINTIODENTUEC
2003
Polyvinyl Methylether Maleic Acid Calcium-Sodium Double Salt Denture AdhesiveKOO · Class 1Denture cleansers & adhesivesMaker
DaburFreshmintIODENTPersonal Care
2011

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
DABUR INDIA LTDFDA reg. 3001413302Silvassa Dadra and Nagar Haveli, IndiaManufacturer, Repacker / relabeler

Sources

FDA establishment registration & device listing (search FDA, owner/operator 9058782). 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.