Not currently registered with FDA under this name

Cariescan , Ltd.

Dundee, Angus, United Kingdom. Named as applicant on 2 dental 510(k) clearances between 2009 and 2011. No establishment is registered with FDA under this exact name today.

Device types listed: 0
Brands and models: 0
510(k) clearances: 22009–2011
Markets registered in: 33 registrations outside the US
Establishments: 0—

510(k) clearances per year, 2000–2026

Registered in 3 markets

Where regulators' registries name Cariescan , Ltd. as the manufacturer or the registration holder of a device.

All markets

RegisteredHome: United KingdomOne marker per market

Market	Regulator	Named as	Name on the registry	Registrations	Issued	Records
United States	FDA	Applicant	Cariescan , Ltd.	2 clearances	2009–2011	Below
Canada	Health Canada	Registration holder	CARIESCAN LIMITED	2	2008–2008	Pure Global AI
Taiwan	TFDA	Manufacturer	CarieScan Limited	1	2013–2013	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 Cariescan , Ltd. as the applicant.

Decided	510(k)	Device	Device type
17 May 2011	K111321	REMOTE VIEW SOFTWARE	NBL Light-Induced Fluorescence Caries Detector
15 Dec 2009	K090598	CARIESCAN PRO	NBL Light-Induced Fluorescence Caries Detector

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.