Registered with FDA

Planet(Shanghai) international Co.,Ltd

shanghai, China. Lists 5 dental device types with FDA across 1 registered establishment.

FDA owner/operator10034846Foreign exporter
Device types listed
5
Brands and models
5
510(k) clearances
0as applicant
Markets registered in
32 registrations outside the US
Establishments
1China

Registered in 3 markets

Where regulators' registries name Planet(Shanghai) international Co.,Ltd as the manufacturer or the registration holder of a device.

All markets
United States: 5 device types listedIsrael: 1 registrationsSouth Korea: 1 registrations
RegisteredHome: ChinaOne marker per market
MarketRegulatorNamed asName on the registryRegistrationsIssuedRecords
United StatesFDAListerPlanet(Shanghai) international Co.,Ltd5 device types—Below
IsraelAMARManufacturerPlanet(Shanghai) International Company Limited1—Pure Global AI
South KoreaMFDSManufacturerPlanet (Shanghai) International Co., Ltd12022–2022Pure 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 Planet(Shanghai) international Co.,Ltd currently lists, by FDA device type, with the brand and model names on the listing.

Device typeCategoryRoleBrands and modelsListed since
Over the Counter Denture CleanserEFT · Class 1Denture cleansers & adhesivesLister
CLEANSER, DENTURE, OVER THE COUNTER
2017
Manual ToothbrushEFW · Class 1ToothbrushesLister
TOOTHBRUSH, MANUAL
2011
Dental FlossJES · Class 1Floss & interdental cleanersLister
FLOSS, DENTAL
2011
Massaging PickJET · Class 1Floss & interdental cleanersLister
PICK, MASSAGING
2011
Paper Saliva AbsorberKHR · Class 1—Lister
ABSORBER, SALIVA, PAPER
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
PLANET(SHANGHAI) INTERNATIONAL CO.,LTDFDA reg. 3008808082shanghai, ChinaForeign exporter

Sources

FDA establishment registration & device listing (search FDA, owner/operator 10034846). 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.