Not currently registered with FDA under this name

Heka Dental A/S

Dk-2635 Ishoj, Denmark. Named as applicant on 1 dental 510(k) clearance between 2015 and 2015. No establishment is registered with FDA under this exact name today.

Device types listed: 0
Brands and models: 0
510(k) clearances: 12015–2015
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 Heka Dental A/S as the manufacturer or the registration holder of a device.

All markets

RegisteredHome: DenmarkOne marker per market

Market	Regulator	Named as	Name on the registry	Registrations	Issued	Records
United States	FDA	Applicant	Heka Dental A/S	1 clearances	2015–2015	Below
Taiwan	TFDA	Manufacturer	HEKA DENTAL A/SHEKA DENTAL APS	2	2006–2016	Pure Global AI
Australia	TGA	Manufacturer	Heka Dental A/S	1	2009–2009	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 Heka Dental A/S as the applicant.

Decided	510(k)	Device	Device type
17 Apr 2015	K150490	UnicLine Mobile	EIA Operative Dental Unit

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.