Not currently registered with FDA under this name

Dentsply Ceramco

Burlington, NJ, United States. Named as applicant on 1 dental 510(k) clearance between 2003 and 2003. No establishment is registered with FDA under this exact name today.

Device types listed: 0
Brands and models: 0
510(k) clearances: 12003–2003
Markets registered in: 692 registrations outside the US
Establishments: 0—

510(k) clearances per year, 2000–2026

Registered in 6 markets

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

All markets

RegisteredHome: United StatesOne marker per market

Market	Regulator	Named as	Name on the registry	Registrations	Issued	Records
United States	FDA	Applicant	Dentsply Ceramco	1 clearances	2003–2003	Below
Canada	Health Canada	Registration holder	DENTSPLY CERAMCO	79	1999–2007	Pure Global AI
South Korea	MFDS	Manufacturer	DENTSPLY CeramcoDentsply Ceramco	5	2003–2012	Pure Global AI
Taiwan	TFDA	Manufacturer	DENTSPLY CERAMCO	4	2006–2016	Pure Global AI
Saudi Arabia	SFDA	Manufacturer	DENTSPLY Ceramco	3	—	Pure Global AI
Costa Rica	Ministerio de Salud	Manufacturer	DENTSPLY CERAMCO	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 Dentsply Ceramco as the applicant.

Decided	510(k)	Device	Device type
22 Aug 2003	K012681	ANKYLOS	DZE Root-Form Endosseous Implant

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.