Not currently registered with FDA under this name

Dentalplus GmbH

Samerberg, Germany. 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: 33 registrations outside the US
Establishments: 0—

510(k) clearances per year, 2007–2026

Registered in 3 markets

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

All markets

RegisteredHome: GermanyOne marker per market

Market	Regulator	Named as	Name on the registry	Registrations	Issued	Records
United States	FDA	Applicant	Dentalplus GmbH	1 clearances	2016–2016	Below
European Union	EUDAMED	Manufacturer	DentalPlus GmbH	2	—	Pure Global AI
Israel	AMAR	Manufacturer	Dental Plus GmbH	1	—	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 Dentalplus GmbH as the applicant.

Decided	510(k)	Device	Device type
19 Jan 2016	K152215	DENTALOS PLUS MONO, DENTALOS PLUS MULTICOLOR	EBG Resin Temporary Crown and Bridge

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.