Data / Medical devices / United States / Philips Oral Healthcare, LLC

Philips Oral Healthcare, LLC: FDA-registered device maker in Bothell, WA, United States, 1 510(k) clearance

Name: Philips Oral Healthcare, LLC FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Philips Oral Healthcare, LLC is registered with the FDA (registration 3026630) in Bothell, WA, United States. It lists 14 device types. The FDA files 1 510(k) clearance under its listings, the newest dated January 10, 2007. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3026630
FEI number: 1000126901
Address: 22100 Bothell Everett Highway, Bothell, WA, United States, 98021
Owner or operator: Philips Medical Systems International BV (9005541)
Roles: Specification developer
First device listed: March 31, 1994
Registered through: 2026
Brand names listed: AirFloss, AirFloss Fill and Charge Station, AirFloss Pro, AirFloss Ultra, Cheek Retractor, Cotton Roll, EVA Tray, Face Bib and more

Devices it lists

Device	Product code	Class	Role	Source
Absorber, Saliva, Paper	KHR	1	Specification developer	accessdata.fda.gov
Accessories, Retractor, Dental	EIF	1	Specification developer	accessdata.fda.gov
Apparatus, Suction, Single Patient Use, Portable, Nonpowered	GCY	1	Specification developer	accessdata.fda.gov
Cotton, Roll	EFN	1	Specification developer	accessdata.fda.gov
Dam, Rubber	EIE	1	Specification developer	accessdata.fda.gov
Heat Source For Bleaching Teeth	EEG	1	Specification developer	accessdata.fda.gov
Material, Impression Tray, Resin	EBH	1	Specification developer	accessdata.fda.gov
Oral Irrigation Kit	OGT	1	Specification developer	accessdata.fda.gov
Shield, Eye, Radiological	IWS	1	Specification developer	accessdata.fda.gov
Shield, Protective, Personnel	KPY	1	Specification developer	accessdata.fda.gov
Toothbrush, Powered	JEQ	1	Specification developer	accessdata.fda.gov
Unit, Oral Irrigation	EFS	1	Specification developer	accessdata.fda.gov
Unit, Ultraviolet Sanitation/Sterilization (For Toothbrushes), Non-Sterile	NOB	1	Specification developer	accessdata.fda.gov
Varnish, Cavity	LBH	2	Specification developer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
January 10, 2007	K062176	RELIEF ACP ORAL CARE GEL	LBH	Substantially Equivalent	Discus Dental, Inc.	accessdata.fda.gov

Compare with other makers

Updated January 10, 2007. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.