Not currently registered with FDA under this name

Biomate Medical Devices Technology Co., Ltd.

Kaohsiung City, Taiwan. Named as applicant on 2 dental 510(k) clearances between 2015 and 2018. No establishment is registered with FDA under this exact name today.

Device types listed: 0
Brands and models: 0
510(k) clearances: 22015–2018
Markets registered in: 328 registrations outside the US
Establishments: 0—

510(k) clearances per year, 2007–2026

Registered in 3 markets

Where regulators' registries name Biomate Medical Devices Technology Co., Ltd. as the manufacturer or the registration holder of a device.

All markets

RegisteredHome: TaiwanOne marker per market

Market	Regulator	Named as	Name on the registry	Registrations	Issued	Records
United States	FDA	Applicant	Biomate Medical Devices Technology Co., Ltd.	2 clearances	2015–2018	Below
Saudi Arabia	SFDA	Manufacturer	BIOMATE MEDICAL DEVICES TECHNOLOGY CO., LTD	20	—	Pure Global AI
United Kingdom	MHRA	Manufacturer	Biomate Medical Devices Technology Co Ltd	8	—	Pure 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 Biomate Medical Devices Technology Co., Ltd. as the applicant.

Decided	510(k)	Device	Device type
26 Oct 2018	K170732	Biomate Dental Implant System	DZE Root-Form Endosseous Implant
20 Mar 2015	K142174	BIOMATE DENTAL IMPLANT SYSTEM	DZE Root-Form Endosseous Implant

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.