Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3026630

FEI Number

1000126901

Entity Name

PHILIPS ORAL HEALTHCARE, LLC

City/State/Country

Bothell, WA, US

Establishment Address

22100 Bothell Everett Highway, Bothell, WA 98021, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

Philips Medical Systems International BV (Owner Number: 9005541)

Owner / Operator Contact Address

Veenpluis 6, Best, NL-NOTA 5684PC, NL

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Face Bib Light Guide Extender Sonicare UV Brush Head Sanitizer Liquidam ZOOM! Whitening Procedure Kit Oral Irrigation Kit Powered Toothbrush Brush Head Philips One Battery Toothbrush by Sonicare Philips One Brush Head by Sonicare Philips One Power Toothbrush by Sonicare Philips Sonicare Cotton Roll Gauze ZOOM 2 Goggles EVA Tray Suction Tip Cheek Retractor Zoom Retractors

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KHR	Absorber, Saliva, Paper	Dental	Class 1	872.6050	2017-08-25
KPY	Shield, Protective, Personnel	Radiology	Class 1	892.6500	2017-08-25
NOB	Unit, Ultraviolet Sanitation/Sterilization (For Toothbrushes), Non-Sterile	Dental	Class 1	872.6855	2007-08-15
EIE	Dam, Rubber	Dental	Class 1	872.6300	2013-04-30
OGT	Oral Irrigation Kit	Dental	Class 1	872.6510	2020-06-19
JEQ	Toothbrush, Powered	Dental	Class 1	872.6865	1994-03-31
EFN	Cotton, Roll	Dental	Class 1	872.6050	2017-08-25
IWS	Shield, Eye, Radiological	Radiology	Class 1	892.6500	2017-08-28
EBH	Material, Impression Tray, Resin	Dental	Class 1	872.3670	2017-08-25
GCY	Apparatus, Suction, Single Patient Use, Portable, Nonpowered	General, Plastic Surgery	Class 1	878.4680	2017-08-25
EIF	Accessories, Retractor, Dental	Dental	Class 1	872.4565	2013-04-30

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Philips Medical Systems International BV

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3038281851	Philips Polska Sp. z o.o.	Lodz Lodzkie, PL
3003584029	Braemar Manufacturing, LLC	San Diego, CA, US
3042175841	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.	Best Noord-Brabant, NL
3008514395	Telcare, LLC	Linwood, PA, US
3004961434	RESPIRATORY TECHNOLOGIES, INC.	Plymouth, MN, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K040797	Britesmile, Inc.	BRITESMILE MASKING CREAM	2004-04-02
K883982	Iberhospitex, S.A.	DRENOVAC	1989-02-23

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0020-04	Vital Concepts, Inc.	1	Huntington Instruments brand Irrigation Aspiration System with Single Spike Tubing and 33 cm Probe, Disposable (single use only), sterile, latex free. Catalog # 55040. Labeled as Manufactured for Huntington Instruments, Ogden Utah.
Z-0021-04	Vital Concepts, Inc.	1	Irrigation Aspiration System with Double Spike Tubing and 33 cm Probe, Disposable (single use only), sterile, latex free. Catalog # 55060. HYDRO-PRO brand labeled as sold by Vital Concepts, Inc., Grand Rapids, Michigan. Huntington Instruments brand labeled as Manufactured for Huntington Instruments, Ogden Utah. Quanta Technologies L.L.C. brand Manufactured for Quanta Technologies, L.L.C., Tucson, AZ. Catalogue # 55060-10 sold in Canada and labeled as Manufactured for Jac-Cell Medic, Dorval, Quebec.
Z-0022-04	Vital Concepts, Inc.	1	HYDRO-PRO brand Irrigation Aspiration System with double Spike Tubing, no Probe, Disposable (single use only), sterile, latex free. Catalog # 55160. Vital Concepts, Inc., Grand Rapids, Michigan.
Z-0023-04	Vital Concepts, Inc.	1	HYDRO-PRO brand Suction-Irrigation System without Probe, Disposable (single use only), sterile, latex free. R-Med Re-Order # 55170R; Distributed by R-Med, Inc., Orgeon, OH
Z-0024-04	Vital Concepts, Inc.	1	Quanta Technologies L.L.C. brand REORDER # LAPKIT 3. Contents 1 -55060 Suction/Irrigation Valve 2- 30012 Insufflation Tubing set 3- 5010 Anti Fog Solution with Sponge. Manufactured for Quanta Technologies, L.L.C., Tucson, AZ.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3026630. Last updated year: 2026. Please use registration number 3026630 when referencing this establishment in official correspondence.