Identity
- Trade Name
- ISSA™ 3 FDA UDI
- Generic Name
- Basic electric toothbrush FDA UDI
- Device Name
- ISSA™ 3 is a powered toothbrush with ultra-soft medical-grade silicone and PBT polymer bristles that remove plaque, and gently massages gums, while the tongue and cheek cleaner on the back helps improve overall oral health. FDA UDI
- Model / Reference
- PEARL PINK FDA UDI
- Description
- ISSA™ 3 is a powered toothbrush with ultra-soft medical-grade silicone and PBT polymer bristles that remove plaque, and gently massages gums, while the tongue and cheek cleaner on the back helps improve overall oral health. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07350092139915 FDA UDI
- FDA Product Code
- JEQ FDA UDI
- GMDN Term
- Basic electric toothbrush FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.6865 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
No
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
Yes
FDA UDI
Category: Basic electric toothbrush
Issa™ 3 by Foreo Inc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 |
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Manufacturer
- Manufacturer
- Foreo Inc
Sources (1)
- FDA UDI b6c1f38a-3eb8-4f3d-abd3-b45d64029b5d 33 fields · synced Jun 6, 2026