Identity
- Trade Name
- PerioSciences LED Electric Toothbrush FDA UDI
- Generic Name
- Basic electric toothbrush FDA UDI
- Device Name
- An electrically powered device designed to be used by a patient-consumer to brush clean their teeth and gums (i.e., to remove plaque, tartar and stains). It comprises a proximal handle and an exchangeable distal head with rows of bristles group in separate tufts. The device provides automated vibratory bristle movement intended to augment brushing. The brush also provides a blue and red LED light to help clean the teeth, stimulate soft tissue, and promote overall oral health. The brush is typically used with toothpaste. FDA UDI
- Model / Reference
- 10610 FDA UDI
- Description
- An electrically powered device designed to be used by a patient-consumer to brush clean their teeth and gums (i.e., to remove plaque, tartar and stains). It comprises a proximal handle and an exchangeable distal head with rows of bristles group in separate tufts. The device provides automated vibratory bristle movement intended to augment brushing. The brush also provides a blue and red LED light to help clean the teeth, stimulate soft tissue, and promote overall oral health. The brush is typically used with toothpaste. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00353238006109 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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Basic electric toothbrush
PerioSciences LED Electric Toothbrush by Perio Sciences, LLC — 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
- Perio Sciences, LLC
Sources (1)
- FDA UDI 254e1459-25ab-41a6-af6a-489dfc982d8e 33 fields · synced Jun 6, 2026