Manufacturer registered with FDA

BrainCool AB

Lund, Sweden. Lists 1 dental device type with FDA across 1 registered establishment, and holds 1 510(k) clearance as applicant.

FDA owner/operator10058195Manufacturer1 clearance in five years

Device types listed: 1
Brands and models: 1
510(k) clearances: 12022–2022
Markets registered in: 56 registrations outside the US
Establishments: 1Sweden

510(k) clearances per year, 2007–2026

Registered in 5 markets

Where regulators' registries name BrainCool AB as the manufacturer or the registration holder of a device.

All markets

RegisteredHome: SwedenOne marker per market

Market	Regulator	Named as	Name on the registry	Registrations	Issued	Records
United States	FDA	Manufacturer	BrainCool AB	1 clearances	2022–2022	Below
European Union	EUDAMED	Manufacturer	BrainCool AB	3	—	Pure Global AI
Australia	TGA	Manufacturer	BrainCool AB	1	2024–2024	Pure Global AI
Japan	PMDA	Registration holder	ＢｒａｉｎＣｏｏｌ　ＡＢ	1	2025–2025	Pure Global AI
Taiwan	TFDA	Manufacturer	BrainCool AB	1	2026–2026	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

Devices listed with FDA

What BrainCool AB currently lists, by FDA device type, with the brand and model names on the listing.

Device type	Category	Role	Brands and models	Listed since
Intraoral Cooling DeviceQUA · Class 2	—	Maker	The Cooral System	2022

Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026

510(k) clearances

Clearances on which FDA names BrainCool AB as the applicant.

Decided	510(k)	Device	Device type
14 Oct 2022	DEN210027	The Cooral System	QUA Intraoral Cooling Device

Registered establishments

Establishment	Location	What it does
BRAINCOOL ABFDA reg. 3014426939	Lund Skane, Sweden	Manufacturer

Sources

FDA establishment registration & device listing (search FDA, owner/operator 10058195). 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.