Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2031532

FEI Number

1000582314

Entity Name

DISCUS DENTAL, LLC

City/State/Country

Ontario, CA, US

Establishment Address

1700 A South Baker Ave, Ontario, CA 91761, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer),Repack or Relabel Medical Device

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

ZOOM! Whitening Procedure Kit Oral Irrigation Kit AirFloss Fill and Charge Station AirFloss Ultra Power Flosser & Toothbrush System AirFloss Pro Philips Power Flosser 7000 Power Flosser Nozzle pack( F1,F2,F3) AirFloss Philips Power Flosser 3000 Philips Sonicare Cordless Power Flosser 3000 Philips Sonicare Cordless Power Flosser 2000 Philips Sonicare Compact Flosser 1000 Philips Sonicare Compact Flosser replacement nozzles ZOOM 2 Goggles EVA Tray Cheek Retractor Zoom Retractors Face Bib Powered Toothbrush Brush Head Philips One Battery Toothbrush by Sonicare Philips One Brush Head by Sonicare Philips One Power Toothbrush by Sonicare Philips Sonicare

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
OGT	Oral Irrigation Kit	Dental	Class 1	872.6510	2020-06-19
EFS	Unit, Oral Irrigation	Dental	Class 1	872.6510	2011-05-05
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
EIF	Accessories, Retractor, Dental	Dental	Class 1	872.4565	2013-04-30
KHR	Absorber, Saliva, Paper	Dental	Class 1	872.6050	2017-08-25
JEQ	Toothbrush, Powered	Dental	Class 1	872.6865	1994-03-31

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
K844318	Pro Pulse, Inc.	ORAL IRRIGATION TIP	1984-11-23

Similar Registrations

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9616088	Convertors de Mexico S. de R.L. de C.V	CD.JUAREZ Chihuahua, MX
3026630	PHILIPS ORAL HEALTHCARE, LLC	Bothell, WA, US
3016872092	WENZHOU ZUOYOU MEDICAL TECHNOLOYG CO.,LTD.	Wenzhou Zhejiang, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2031532. Last updated year: 2026. Please use registration number 2031532 when referencing this establishment in official correspondence.