Not currently registered with FDA under this name

Ortholution Co., Ltd.

Dunwoody, GA, United States. Named as applicant on 3 dental 510(k) clearances between 2005 and 2008. No establishment is registered with FDA under this exact name today.

Device types listed: 0
Brands and models: 0
510(k) clearances: 32005–2008
Markets registered in: 1United States
Establishments: 0—

510(k) clearances per year, 2000–2026

510(k) clearances

Clearances on which FDA names Ortholution Co., Ltd. as the applicant.

Decided	510(k)	Device	Device type
25 Nov 2008	K082838	ORLUS MINI SCREW	DZE Root-Form Endosseous Implant
8 Sep 2006	K052968	MODIFICATION TO: ORLUS MINI SCREW	DZE Root-Form Endosseous Implant
1 Jun 2005	K050568	ORLUS MINI SCREW	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.