Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1122110

FEI Number

1122110

Entity Name

ORATEC CORP.

City/State/Country

MANASSAS, VA, US

Establishment Address

12181 Brady Lane, MANASSAS, VA 20109, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

ORATEC CORP. (Owner Number: 1122110)

Owner / Operator Contact Address

12181 BALLS FORD RD., --, MANASSAS, VA 20109, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Viajet

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EFS	Unit, Oral Irrigation	Dental	Class 1	872.6510	1997-06-19

Official Correspondent

WILLIAM LANDERS

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

ORATEC CORP.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K844318	Pro Pulse, Inc.	ORAL IRRIGATION TIP	1984-11-23

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1122110. Last updated year: 2026. Please use registration number 1122110 when referencing this establishment in official correspondence.