FDA Registration
Active
🇺🇸 United States
DISCUS DENTAL, LLC
Reg #: 2031532
·
FEI: 1000582314
·
Expires 2026
Products
13
Proprietary Names
31
Establishment Types
3
Classifications
13
Registration Details
- Registration Name
- DISCUS DENTAL, LLC
- Registration Number
- 2031532
- FEI Number
- 1000582314
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 1700 A South Baker Ave
- City
- Ontario
- State
- CA
- ZIP
- 91761
- 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 |
|---|---|---|---|---|---|
| Oral Irrigation Kit | OGT | Class 1 | Dental | No | 2020-06-19 |
| Unit, Oral Irrigation | EFS | Class 1 | Dental | No | 2011-05-05 |
| Shield, Eye, Radiological | IWS | Class 1 | Radiology | No | 2017-08-28 |
| Material, Impression Tray, Resin | EBH | Class 1 | Dental | No | 2017-08-25 |
| Accessories, Retractor, Dental | EIF | Class 1 | Dental | No | 2013-04-30 |
| Absorber, Saliva, Paper | KHR | Class 1 | Dental | No | 2017-08-25 |
| Toothbrush, Powered | JEQ | Class 1 | Dental | No | 1994-03-31 |
| Shield, Protective, Personnel | KPY | Class 1 | Radiology | No | 2017-08-25 |
| Dam, Rubber | EIE | Class 1 | Dental | No | 2013-04-30 |
| Heat Source For Bleaching Teeth | EEG | Class 1 | Dental | No | 2013-04-30 |
| Apparatus, Suction, Single Patient Use, Portable, Nonpowered | GCY | Class 1 | General, Plastic Surgery | No | 2017-08-25 |
| Varnish, Cavity | LBH | Class 2 | Dental | No | 2013-04-30 |
| Cotton, Roll | EFN | Class 1 | Dental | No | 2017-08-25 |
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
Light Guide Extender
Liquidam
Zoom WhiteSpeed Lamp
Suction Tip
Relief ACP Oral Care Gel
Cotton Roll
Gauze
Establishment Types
Repack or Relabel Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)
Manufacture Medical Device