Not currently registered with FDA under this name

Orthotech

Tampa, FL, United States. Named as applicant on 1 dental 510(k) clearance between 1994 and 1994. No establishment is registered with FDA under this exact name today.

Device types listed: 0
Brands and models: 0
510(k) clearances: 11994–1994
Markets registered in: 4149 registrations outside the US
Establishments: 0—

510(k) clearances per year, 1990–2026

Registered in 4 markets

Where regulators' registries name Orthotech as the manufacturer or the registration holder of a device.

All markets

RegisteredHome: United StatesOne marker per market

Market	Regulator	Named as	Name on the registry	Registrations	Issued	Records
United States	FDA	Applicant	Orthotech	1 clearances	1994–1994	Below
India	CDSCO	Registration holder	ORTHOTECH	142	2013–2013	Pure Global AI
Australia	TGA	Registration holder	Orthotech Pty Ltd	6	2019–2020	Pure Global AI
European Union	EUDAMED	Manufacturer	ORTHOTECH Co., Ltd	1	—	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 Orthotech as the applicant.

Decided	510(k)	Device	Device type
23 Mar 1994	K933080	ORTHOTECH DURA-GOLD BARCKETS	EJF Orthodontic Metal Bracket

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.