Identity
- Trade Name
- Philips Sonicare FDA UDI
- Generic Name
- Water jet flosser FDA UDI
- Model / Reference
- HX8424/50 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00075020085696 FDA UDI
- FDA Product Code
- JEQ FDA UDIEFS FDA UDI
- GMDN Term
- Water jet flosser FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.6865 FDA UDI872.6510 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Basic electric toothbrushWater jet flosser
A comprehensive electrically-powered dental device intended to provide a high-pressure water jet for dental flossing (removal of plaque and/or debris from between teeth) using a dedicated handpiece. It is normally available over-the-counter (OTC) for use in the home or healthcare facility.
Similar devices
Also classified as Water jet flosser.
- COOSKIN — Ningbo Cooskin Stationery Co., Ltd. · Class I
- Soniclean — ASHTEL STUDIOS, INC. · Class I
- Ordo — ORDOCLUB LTD · Class I
- COOSKIN — Ningbo Cooskin Stationery Co., Ltd. · Class I
- Risuntech — Shenzhen Risun Technology Co., Ltd. · Class I
- SmileSet WF500 Water Flosser – White — ORTHO DENTAL LAB, LLC · Class I
- Mysmile — ABrite Tech (Shanghai) Co., Ltd. · Class I
- VIVE — VIVE HEALTH LLC · Class I
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Philips Oral Healthcare, Llc
Sources (1)
- FDA UDI e51c27af-7bff-425d-8836-6fbc5dd7c8eb 32 fields · synced Jul 18, 2026