Dental Device Guide
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Manufacturer registered with FDA

Truly Instrument Ltd

KWAI CHUNG, Hong Kong SAR China. Lists 1 dental device type with FDA across 1 registered establishment.

FDA owner/operator9054344Contract manufacturer
Device types listed
1
Brands and models
1
510(k) clearances
0as applicant
Markets registered in
44 registrations outside the US
Establishments
1Hong Kong SAR China

Registered in 4 markets

Where regulators' registries name Truly Instrument Ltd as the manufacturer or the registration holder of a device.

All markets
United States: 1 device types listedCanada: 2 registrationsAustralia: 1 registrationsSouth Korea: 1 registrations
RegisteredHome: Hong Kong SAR ChinaOne marker per market
MarketRegulatorNamed asName on the registryRegistrationsIssuedRecords
United StatesFDAManufacturerTruly Instrument Ltd1 device types—Below
CanadaHealth CanadaRegistration holderTRULY INSTRUMENT LIMITED22016–2016Pure Global AI
AustraliaTGAManufacturerTruly Instrument Ltd12021–2021Pure Global AI
South KoreaMFDSManufacturerTruly Instrument Ltd.12009–2009Pure 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 Truly Instrument Ltd currently lists, by FDA device type, with the brand and model names on the listing.

Device typeCategoryRoleBrands and modelsListed since
Battery-Powered Ionic ToothbrushMMD · Class 1ToothbrushesMaker
Truly Power Toothbrush
2002

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
TRULY INSTRUMENT LIMITEDFDA reg. 3003657019KWAI CHUNG, Hong Kong SAR ChinaContract manufacturer

Sources

FDA establishment registration & device listing (search FDA, owner/operator 9054344). 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.