Not currently registered with FDA under this name

Orasystems

Morris Plains, NJ, United States. Named as applicant on 3 dental 510(k) clearances between 2000 and 2000. No establishment is registered with FDA under this exact name today.

Device types listed: 0
Brands and models: 0
510(k) clearances: 32000–2000
Markets registered in: 1United States
Establishments: 0—

510(k) clearances per year, 2000–2026

510(k) clearances

Clearances on which FDA names Orasystems as the applicant.

Decided	510(k)	Device	Device type
4 Dec 2000	K000846	TKD SCALERS	ELC Ultrasonic Scaler
5 Oct 2000	K000848	TDK HANDPIECES	EFB Dental Air-Powered Handpiece
27 Sep 2000	K000847	ORALUBE	EFB Dental Air-Powered Handpiece

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.