Manufacturer registered with FDA

Oratec Corp.

MANASSAS, VA, United States. Lists 1 dental device type with FDA across 1 registered establishment, and holds 1 510(k) clearance as applicant.

FDA owner/operator1122110Specification developer

Device types listed: 1
Brands and models: 1
510(k) clearances: 11988–1988
Markets registered in: 1United States
Establishments: 1United States

510(k) clearances per year, 1980–2026

Devices listed with FDA

What Oratec Corp. currently lists, by FDA device type, with the brand and model names on the listing.

Device type	Category	Role	Brands and models	Listed since
Oral Irrigation UnitEFS · Class 1	Oral irrigators	Maker	Viajet	1997

Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026

510(k) clearances

Clearances on which FDA names Oratec Corp. as the applicant.

Decided	510(k)	Device	Device type
26 Jul 1988	K881992	SYRETTE	EKJ Operative Burnisher

Registered establishments

Establishment	Location	What it does
ORATEC CORP.FDA reg. 1122110	MANASSAS, VA, United States	Specification developer

Sources

FDA establishment registration & device listing (search FDA, owner/operator 1122110). 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.