Identity
- Trade Name
- ISSA 4 Smile FDA UDI
- Generic Name
- Basic electric toothbrush FDA UDI
- Device Name
- ISSA 4 Smile is for use at home and to promote overall oral hygiene by cleaning your teeth and gums only. FDA UDI
- Model / Reference
- Enchanted Violet FDA UDI
- Description
- ISSA 4 Smile is for use at home and to promote overall oral hygiene by cleaning your teeth and gums only. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07350120793041 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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Basic electric toothbrush
ISSA 4 Smile 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 dc856250-db19-4e25-a83e-a4a0d560af00 33 fields · synced Jun 8, 2026