Not currently registered with FDA under this name

Btlock Srl

Montecchio Maggiore, Vicenza, Italy. Named as applicant on 2 dental 510(k) clearances between 2008 and 2009. No establishment is registered with FDA under this exact name today.

Device types listed: 0
Brands and models: 0
510(k) clearances: 22008–2009
Markets registered in: 36 registrations outside the US
Establishments: 0—

510(k) clearances per year, 2000–2026

Registered in 3 markets

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

All markets

RegisteredHome: ItalyOne marker per market

Market	Regulator	Named as	Name on the registry	Registrations	Issued	Records
United States	FDA	Applicant	Btlock Srl	2 clearances	2008–2009	Below
South Korea	MFDS	Manufacturer	BTLock S.r.lBTLock S.R.L.	5	2005–2005	Pure Global AI
Taiwan	TFDA	Manufacturer	BTLOCK S.R.L	1	2006–2006	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 Btlock Srl as the applicant.

Decided	510(k)	Device	Device type
27 Mar 2009	K083869	BT-TITE CV3, MINI IMPLANT, MINI SINGLE, SLOT IMPLANT, MODEL(S) DDDIII BTICV3, 1, AND DDDIIIBTISI	DZE Root-Form Endosseous Implant
4 Apr 2008	K073458	BT-TITE ONE(BTICV1), BT-TITE STANDARD(BTIVSM), BT-TITE CV2(BTICV2)	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.