Not currently registered with FDA under this name

Bluesom

Orvault, France. Named as applicant on 1 dental 510(k) clearance between 2016 and 2016. No establishment is registered with FDA under this exact name today.

Device types listed: 0
Brands and models: 0
510(k) clearances: 12016–2016
Markets registered in: 21 registrations outside the US
Establishments: 0—

510(k) clearances per year, 2007–2026

Registered in 2 markets

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

All markets

RegisteredHome: FranceOne marker per market

Market	Regulator	Named as	Name on the registry	Registrations	Issued	Records
United States	FDA	Applicant	Bluesom	1 clearances	2016–2016	Below
Brazil	ANVISA	Manufacturer	BLUESOM	1	2017–2017	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 Bluesom as the applicant.

Decided	510(k)	Device	Device type
15 Dec 2016	K162192	BluePro	LRK Anti-Snoring Device

Some of these clearances are listed with FDA today by another company: Newsom (1).

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.