Not currently registered with FDA under this name

Aspen Laboratories, Inc.

Englewood, CO, United States. Named as applicant on 1 dental 510(k) clearance between 1987 and 1987. No establishment is registered with FDA under this exact name today.

Device types listed: 0
Brands and models: 0
510(k) clearances: 11987–1987
Markets registered in: 2571 registrations outside the US
Establishments: 0—

510(k) clearances per year, 1980–2026

Registered in 2 markets

Where regulators' registries name Aspen Laboratories, 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	Aspen Laboratories, Inc.	1 clearances	1987–1987	Below
India	CDSCO	Registration holder	ASPEN LABORATORIES PRIVATE LIMITEDAspen Laboratories Pvt. Ltd. · ASPEN LABORATORIES PVT. LTD.	571	2019–2026	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 Aspen Laboratories, Inc. as the applicant.

Decided	510(k)	Device	Device type
8 Jun 1987	K871648	TMJ CANNULA SET	DZI Powered Bone Drill

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.