Not currently registered with FDA under this name

Hallim Dentech Co., Ltd.

Fullerton, CA, United States. Named as applicant on 1 dental 510(k) clearance between 2011 and 2011. No establishment is registered with FDA under this exact name today.

Device types listed
0
Brands and models
0
510(k) clearances
12011–2011
Markets registered in
22 registrations outside the US
Establishments
0—
2011: 120102020

510(k) clearances per year, 2007–2026

Registered in 2 markets

Where regulators' registries name Hallim Dentech Co., Ltd. as the manufacturer or the registration holder of a device.

All markets
United States: 1 clearancesAustralia: 2 registrations
RegisteredHome: United StatesOne marker per market
MarketRegulatorNamed asName on the registryRegistrationsIssuedRecords
United StatesFDAApplicantHallim Dentech Co., Ltd.1 clearances2011–2011Below
AustraliaTGAManufacturerHallim Dentech Co Ltd22012–2018Pure 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 Hallim Dentech Co., Ltd. as the applicant.

Decided510(k)DeviceDevice type
25 Feb 2011K102223CHALLENGE-EVEREIA Operative Dental Unit

Some of these clearances are listed with FDA today by another company: Hallim Point Implant Co., Ltd. (1).

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.