Not currently registered with FDA under this name

Orthoplus, Inc.

Santa Rosa, CA, 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: 58 registrations outside the US
Establishments: 0—

510(k) clearances per year, 1990–2026

Registered in 5 markets

Where regulators' registries name Orthoplus, Inc. 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	Orthoplus, Inc.	1 clearances	1994–1994	Below
Malaysia	MDA	Registration holder	ORTHOPLUS SDN BHD	4	2025–2025	Pure Global AI
European Union	EUDAMED	Manufacturer	ORTHOPLUS	2	—	Pure Global AI
China	NMPA	Registration holder	正星有限公司ORTHOPLUS SAS	1	—	Pure Global AI
South Korea	MFDS	Manufacturer	ORTHOPLUS	1	2016–2016	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 Orthoplus, Inc. as the applicant.

Decided	510(k)	Device	Device type
13 Jul 1994	K942492	ADJUSTABLE BITE CORRECTOR	ECO Orthodontic Spring

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.