Manufacturer registered with FDA
Philips Medical Systems International BV
Best, Netherlands. Lists 13 dental device types with FDA across 8 registered establishments, and holds 16 510(k) clearances as applicant.
- Device types listed
- 13
- Brands and models
- 31
- 510(k) clearances
- 162002–2010
- Markets registered in
- 161,833 registrations outside the US
- Establishments
- 8Austria, Canada, China +3
510(k) clearances per year, 2000–2026
Registered in 16 markets
Where regulators' registries name Philips Medical Systems International BV as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | Philips Medical Systems International BV | 16 clearances | 2002–2010 | Below |
| European Union | EUDAMED | Registration holder | Respironics Inc.Philips Consumer Lifestyle B.V. | 1,286 | — | Pure Global AI |
| Taiwan | TFDA | Manufacturer | RESPIRONICS INC.Respironics, Inc. · Respironics Inc. · +2 | 159 | 1990–2025 | Pure Global AI |
| Canada | Health Canada | Registration holder | PHILIPS ORAL HEALTHCARE, LLCDISCUS DENTAL, LLC · PHILIPS CONSUMER LIFESTYLE BV · +1 | 155 | 1999–2026 | Pure Global AI |
| Colombia | INVIMA | Registration holder | DISCUS DENTAL LLCDISCUS DENTAL LLC. · DISCUS DENTAL INC. · +2 | 77 | — | Pure Global AI |
| Brazil | ANVISA | Manufacturer | RESPIRONICS, INCPHILIPS CONSUMER LIFESTYLE BV · RESPIRONICS, INC. · +1 | 47 | 2011–2026 | Pure Global AI |
| Israel | AMAR | Manufacturer | Respironics Inc.Philips Consumer Lifestyle B.V. · Respironics, Inc · +2 | 31 | — | Pure Global AI |
| China | NMPA | Registration holder | 伟康股份有限公司Respironics, Inc.伟康股份有限公司Respironics,Inc. · 迪斯卡仕牙齿护理有限公司Discus Dental, LLC · +2 | 22 | — | Pure Global AI |
| South Korea | MFDS | Manufacturer | Discus Dental, LLCDiscus Dental LLC · Discus Dental LLC. · +2 | 19 | 2003–2011 | Pure Global AI |
| Peru | DIGEMID | Manufacturer | RESPIRONICS, INCRESPIRONICS INC · DISCUS DENTAL, LLC · +1 | 13 | 2017–2026 | Pure Global AI |
| Costa Rica | Ministerio de Salud | Manufacturer | DISCUS DENTAL, LLC | 8 | — | Pure Global AI |
| Saudi Arabia | SFDA | Manufacturer | PHILIPS CONSUMER LIFESTYLE B.V.Discus Dental, LLC. | 6 | — | Pure Global AI |
| Australia | TGA | Manufacturer | Discus Dental LLCPhilips Consumer Lifestyle BV | 4 | 2019–2025 | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | Philips Consumer Lifestyle B.V. | 4 | — | Pure Global AI |
| Hong Kong | MDD | Manufacturer | Philips Consumer Lifestyle B.V. | 1 | 2016–2016 | Pure Global AI |
| Serbia | ALIMS | Manufacturer | PHILIPS CONSUMER LIFESTYLE B.V. | 1 | 2022–2022 | Pure Global AI |
Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026
Devices listed with FDA
What Philips Medical Systems International BV currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Powered ToothbrushJEQ · Class 1 | Toothbrushes | Maker | Philips One Battery Toothbrush by SonicarePhilips One Brush Head by SonicarePhilips One Power Toothbrush by SonicarePhilips SonicarePowered Toothbrush Brush Head | 1994 |
| Oral Irrigation UnitEFS · Class 1 | Oral irrigators | Maker | AirFlossAirFloss Fill and Charge StationAirFloss ProAirFloss UltraPhilips Power Flosser 3000Philips Power Flosser 7000Philips Sonicare Compact Flosser 1000Philips Sonicare Compact Flosser replacement nozzlesPhilips Sonicare Cordless Power Flosser 2000Philips Sonicare Cordless Power Flosser 3000 2 morePower Flosser & Toothbrush SystemPower Flosser Nozzle pack( F1,F2,F3) | 2011 |
| Resin Impression Tray MaterialEBH · Class 1 | Impression trays | Maker | EVA Tray | 2017 |
| Heat Source for Bleaching TeethEEG · Class 1 | Teeth whitening lights | Maker | Zoom WhiteSpeed Lamp | 2013 |
| Roll CottonEFN · Class 1 | — | Maker | Cotton RollGauze | 2017 |
| Rubber DamEIE · Class 1 | Rubber dam systems | Maker | Liquidam | 2013 |
| Dental Retractor AccessoriesEIF · Class 1 | Dental hand instruments | Maker | Cheek RetractorZoom Retractors | 2013 |
| Paper Saliva AbsorberKHR · Class 1 | — | Maker | Face Bib | 2017 |
| Cavity VarnishLBH · Class 2 | Sealants & varnishes | Maker | Relief ACP Oral Care Gel | 2013 |
| Anti-Snoring DeviceLRK · Class 2 | Anti-snoring & jaw-repositioning devices | Maker | SnoreSilencer | 2010 |
| Cervical (for Mild Sleep Apnea) PillowMYB · Class 2 | — | Maker | NightBalance | 2019 |
| Ultraviolet Sanitation/Sterilization (for Toothbrushes) Unit Non-SterileNOB · Class 1 | — | Maker | Sonicare UV Brush Head Sanitizer | 2007 |
| Oral Irrigation KitOGT · Class 1 | — | Maker | Oral Irrigation KitZOOM! Whitening Procedure Kit | 2020 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
510(k) clearances
Clearances on which FDA names Philips Medical Systems International BV as the applicant, including filings under its other names.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 30 Jun 2010 | K101612 | ZEN CORDLESS PROPHY SYSTEM | EKX Ac-Powered Direct Drive Handpiece |
| 12 May 2010 | K101215 | NUANCE | EBF Resin Tooth Shade Material |
| 12 Feb 2010 | K093208 | SIMPLISEAL | KIF Root Canal Filling Resin |
| 11 Dec 2009 | K092417 | INSIGHT ULTRASONIC INSERTS | ELC Ultrasonic Scaler |
| 20 Dec 2007 | K073518 | FLASHLITE REBEL* | EBZ Ultraviolet Activator for Polymerization |
| 10 Jan 2007 | K062176 | RELIEF ACP ORAL CARE GEL | LBH Cavity Varnish |
| 5 Aug 2005 | K052090 | SPLASH! IMPRESSION MATERIAL DEVICE | ELW Impression Material |
| 13 Jul 2005 | K051776 | PROTEGE ULTRASONIC INSERT | ELC Ultrasonic Scaler |
| 2 Jul 2004 | K040416 | SONICARE ADVANCE TOOTHBRUSH, MODEL 4900 | JEQ Powered Toothbrush |
| 18 Jun 2004 | K033785 | PROACTIVE CARE PROPHYLAXIS PASTE WITH FLUORIDE | EJR Oral Cavity Abrasive Polishing Agent |
| 25 Mar 2004 | K040053 | PRECISION VPS IMPRESSION MATERIAL | ELW Impression Material |
| 6 Feb 2004 | K033823 | RESPIRONICS CUSTOM II ORAL APPLIANCE | LRK Anti-Snoring Device |
| 6 Feb 2004 | K033822 | RESPIRONICS CUSTOM I ORAL APPLIANCE | LRK Anti-Snoring Device |
| 9 May 2003 | K030776 | MEGA BITE REGISTRATION - DENTAL BITE REGISTRATION MATERIAL | ELW Impression Material |
| 17 Jan 2003 | K023748 | FLASH-LITE II LED DENTAL CURING LIGHT | EBZ Ultraviolet Activator for Polymerization |
| 20 Aug 2002 | K022184 | FLASH-LITE LED DENTAL CURING LIGHT | EBZ Ultraviolet Activator for Polymerization |
Some of these clearances are listed with FDA today by another company: Den-Mat Holdings, LLC (5), Smylio (1), Twin River Group (1), Kettenbach GmbH & Co. KG (1).
Also lists devices cleared under other names
Philips Medical Systems International BV lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.
Original applicants: Nightbalance BV (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 5 Jun 2018 | K180608 | Lunoa System | Nightbalance BV | MYB Cervical (for Mild Sleep Apnea) Pillow |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| DISCUS DENTAL, LLCFDA reg. 2031532 | Ontario, CA, United States | Contract manufacturer, Manufacturer, Repacker / relabeler |
| Philips Austria GmbHFDA reg. 3003630806 | Klagenfurt Karnten, Austria | Contract manufacturer |
| Philips Consumer Lifestyle B.V.FDA reg. 3007601164 | Drachten Fryslan, Netherlands | Contract manufacturer |
| Philips DAP Care Company of Zhuhai SEZ LimitedFDA reg. 3017403359 | Zhuhai Guangdong, China | Contract manufacturer, Foreign exporter, Repacker / relabeler |
| Philips Electronics LtdFDA reg. 3000126629 | Mississauga Ontario, Canada | Foreign exporter |
| PHILIPS ORAL HEALTHCARE, LLCFDA reg. 3026630 | Bothell, WA, United States | Specification developer |
| PT PHILIPS INDUSTRIES BATAMFDA reg. 3010047475 | Muka Kuning, Batam Riau, Indonesia | Contract manufacturer, Foreign exporter |
| RESPIRONICS INC.FDA reg. 2518422 | MURRYSVILLE, PA, United States | Complaint file establishment, Specification developer |
Other names on FDA records
Discus Dental, LLC · Philips Oral Healthcare, LLC · Respironics, Inc. · Philips Consumer Lifestyle B.V. · Philips Electronics Ltd. · Philips Austria GmbH · Philips DAP Care Company of Zhuhai SEZ Limited · PT Philips Industries Batam
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9005541, 1217116, 2518422). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.