Not currently registered with FDA under this name

Mathys, Ltd.

San Diego, CA, United States. Named as applicant on 2 dental 510(k) clearances between 1991 and 2010. No establishment is registered with FDA under this exact name today.

Device types listed: 0
Brands and models: 0
510(k) clearances: 21991–2010
Markets registered in: 28 registrations outside the US
Establishments: 0—

510(k) clearances per year, 1990–2026

Registered in 2 markets

Where regulators' registries name Mathys, Ltd. 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	Mathys, Ltd.	2 clearances	1991–2010	Below
Canada	Health Canada	Registration holder	MATHYS LTD.	8	1999–1999	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 Mathys, Ltd. as the applicant.

Decided	510(k)	Device	Device type
15 Sep 2010	K101426	CEROS TCP GRANULES	LYC Synthetic Bone Grafting Material
29 Jan 1991	K900136	CEROS 80 (HA)	LYC Synthetic Bone Grafting Material

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.