Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3018418236

FEI Number

3018418236

Entity Name

ORALKLEEN LLC

City/State/Country

Phoenix, AZ, US

Establishment Address

1 N. 1ST ST., STE 7200, Phoenix, AZ 85004, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

ORALKLEEN INC (Owner Number: 10086130)

Owner / Operator Contact Address

1 N. 1ST ST., STE 7200, Phoenix, AZ 85004, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

ORALKLEEN ORALKLEEN ORALKLEEN ORALKLEEN

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EAZ	Light, Operating, Dental	Dental	Class 1	872.4630	2022-10-17
JEQ	Toothbrush, Powered	Dental	Class 1	872.6865	2022-10-17
NSB	Patient Personal Hygiene Kit	Dental	Class 1	872.6855	2022-10-17
JOL	Catheter And Tip, Suction	General Hospital	Class 2	880.6740	2022-10-17

Official Correspondent

Kurt Kenzler

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

ORALKLEEN INC

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

View Entity Profile →

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0007-2013	Invuity, Inc.	2	BriteField illuminated Suction Device; Model numbers 8Fr, 10Fr and 12Fr, Kit (included 8Fr, 10Fr and 12Fr and a sterilization tray. The Invuity Brite Field Illuminated Suction Device is intended to aspirate from the surgical site and to provide illumination from a high intensity light source.

Similar Registrations

Registration Number	Establishment Name	Location
3015703934	MEDFRUITION ELECTRONICS TECHNOLOGY CO., LTD	Foshan City Guangdong, CN
3014766731	TAKARA BELMONT CORPORATION, OSAKA FACTORY	OSAKA, JP
3023443842	HENAN BAISTRA MEDICAL DEVICES LIMITED	Zhengzhou Henan, CN
2031508	TPC ADVANCED TECHNOLOGY, INC.	City Industry, CA, US
3022226	FOREST DENTAL EQUIPMENT	HILLSBORO, OR, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3018418236. Last updated year: 2026. Please use registration number 3018418236 when referencing this establishment in official correspondence.