Not currently registered with FDA under this name

Xo Care A/S

Lagunga Beach, CA, United States. Named as applicant on 1 dental 510(k) clearance between 2003 and 2003. No establishment is registered with FDA under this exact name today.

Device types listed: 0
Brands and models: 0
510(k) clearances: 12003–2003
Markets registered in: 512 registrations outside the US
Establishments: 0—

510(k) clearances per year, 2000–2026

Registered in 5 markets

Where regulators' registries name Xo Care A/S 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	Xo Care A/S	1 clearances	2003–2003	Below
European Union	EUDAMED	Manufacturer	XO CARE A/S	5	—	Pure Global AI
China	NMPA	Registration holder	爱克斯欧护理股份有限公司XO CARE A/S爱克斯欧护理股份有限公司 XO CARE A/S	3	—	Pure Global AI
South Korea	MFDS	Manufacturer	XO-CARE A/S	2	2003–2003	Pure Global AI
United Kingdom	MHRA	Manufacturer	XO CARE A/S	2	—	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 Xo Care A/S as the applicant.

Decided	510(k)	Device	Device type
29 Apr 2003	K023672	X O ODONTOSURGE 4	EKZ Dental Electrosurgical Unit and Accessories

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.