FDA Registration
Active
🇺🇸 United States
PHILIPS ORAL HEALTHCARE, LLC
Reg #: 3026630
·
FEI: 1000126901
·
Expires 2026
Products
14
Proprietary Names
32
Establishment Types
1
Classifications
14
Registration Details
- Registration Name
- PHILIPS ORAL HEALTHCARE, LLC
- Registration Number
- 3026630
- FEI Number
- 1000126901
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 22100 Bothell Everett Highway
- City
- Bothell
- State
- WA
- ZIP
- 98021
- Country
- US
Regulatory Submissions
- 510(k) Number
- K062176
Owner / Operator
- Firm Name
- Philips Medical Systems International BV
- Operator Number
- 9005541
- Address
- Veenpluis 6
- City
- Best
- State
- NL-NOTA
- Postal Code
- 5684PC
- Country
- NL
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Absorber, Saliva, Paper | KHR | Class 1 | Dental | No | 2017-08-25 |
| Shield, Protective, Personnel | KPY | Class 1 | Radiology | No | 2017-08-25 |
| Unit, Ultraviolet Sanitation/Sterilization (For Toothbrushes), Non-Sterile | NOB | Class 1 | Dental | No | 2007-08-15 |
| Dam, Rubber | EIE | Class 1 | Dental | No | 2013-04-30 |
| Oral Irrigation Kit | OGT | Class 1 | Dental | No | 2020-06-19 |
| Toothbrush, Powered | JEQ | Class 1 | Dental | No | 1994-03-31 |
| Cotton, Roll | EFN | Class 1 | Dental | No | 2017-08-25 |
| Shield, Eye, Radiological | IWS | Class 1 | Radiology | No | 2017-08-28 |
| Material, Impression Tray, Resin | EBH | Class 1 | Dental | No | 2017-08-25 |
| Apparatus, Suction, Single Patient Use, Portable, Nonpowered | GCY | Class 1 | General, Plastic Surgery | No | 2017-08-25 |
| Accessories, Retractor, Dental | EIF | Class 1 | Dental | No | 2013-04-30 |
| Unit, Oral Irrigation | EFS | Class 1 | Dental | No | 2011-05-05 |
| Heat Source For Bleaching Teeth | EEG | Class 1 | Dental | No | 2013-04-30 |
| Varnish, Cavity | LBH | Class 2 | Dental | No | 2013-04-30 |
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
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 WhiteSpeed Lamp
Relief ACP Oral Care Gel
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility