Not currently registered with FDA under this name

Ardent, Inc.

Amherst, NY, United States. Named as applicant on 1 dental 510(k) clearance between 2013 and 2013. No establishment is registered with FDA under this exact name today.

Device types listed: 0
Brands and models: 0
510(k) clearances: 12013–2013
Markets registered in: 2200 registrations outside the US
Establishments: 0—

510(k) clearances per year, 2007–2026

Registered in 2 markets

Where regulators' registries name Ardent, 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	Ardent, Inc.	1 clearances	2013–2013	Below
Canada	Health Canada	Registration holder	ARDENT, INC.	200	2006–2013	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 Ardent, Inc. as the applicant.

Decided	510(k)	Device	Device type
20 Feb 2013	K123613	SYNSPAR ADVANCED	EIH Porcelain Powder

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.