Not currently registered with FDA under this name

Smartpractice

Phoenix, AZ, United States. Named as applicant on 1 dental 510(k) clearance between 2002 and 2002. No establishment is registered with FDA under this exact name today.

Device types listed: 0
Brands and models: 0
510(k) clearances: 12002–2002
Markets registered in: 415 registrations outside the US
Establishments: 0—

510(k) clearances per year, 2000–2026

Registered in 4 markets

Where regulators' registries name Smartpractice 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	Smartpractice	1 clearances	2002–2002	Below
European Union	EUDAMED	Manufacturer	SmartPractice	12	—	Pure Global AI
Brazil	ANVISA	Manufacturer	SMARTPRACTICE	2	2011–2013	Pure Global AI
United Kingdom	MHRA	Manufacturer	SmartPractice	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 Smartpractice as the applicant.

Decided	510(k)	Device	Device type
11 Dec 2002	K023232	SPLATRFREE SWANGLE 360 DISPOSABLE PROPHYLAXIS ANGLE	EFS Oral Irrigation Unit

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.