Not currently registered with FDA under this name

Takiron Co., Ltd.

Himeji, Hyogo, Japan. Named as applicant on 1 dental 510(k) clearance between 2007 and 2007. No establishment is registered with FDA under this exact name today.

Device types listed
0
Brands and models
0
510(k) clearances
12007–2007
Markets registered in
32 registrations outside the US
Establishments
0—
2007: 1200020102020

510(k) clearances per year, 2000–2026

Registered in 3 markets

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

All markets
United States: 1 clearancesColombia: 1 registrationsTaiwan: 1 registrations
RegisteredHome: JapanOne marker per market
MarketRegulatorNamed asName on the registryRegistrationsIssuedRecords
United StatesFDAApplicantTakiron Co., Ltd.1 clearances2007–2007Below
ColombiaINVIMAManufacturerTAKIRON CO LTD1—Pure Global AI
TaiwanTFDAManufacturerTAKIRON CO., LTD.11996–1996Pure 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 Takiron Co., Ltd. as the applicant.

Decided510(k)DeviceDevice type
14 Mar 2007K061881OSTEOTRANS -MX BIOABSORBABLE BONE FIXATION SYSTEMJEY Bone Plate

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.