Identity
- Trade Name
- WeSensor FDA UDI
- Generic Name
- Dental digital imaging sensor, intraoral FDA UDI
- Device Name
- The WeSensor is an intraoral digital x-ray sensor. This model uses a scintillator made from Thallium-doped Cesium Iodide (CsI:Tl) and Sodium Iodide (NaI:Tl). This model also includes an extra filter layer in the sensor. This unique structure of the scintillator and filter layer further enhances image quality. The dimension of this sensor is 37.0 mm × 27.0 mm× 12.0 mm. FDA UDI
- Model / Reference
- F150A FDA UDI
- Description
- The WeSensor is an intraoral digital x-ray sensor. This model uses a scintillator made from Thallium-doped Cesium Iodide (CsI:Tl) and Sodium Iodide (NaI:Tl). This model also includes an extra filter layer in the sensor. This unique structure of the scintillator and filter layer further enhances image quality. The dimension of this sensor is 37.0 mm × 27.0 mm× 12.0 mm. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08809840720022 FDA UDI
- 510(k) Number
- K230916 FDA UDI
- FDA Product Code
- MUH FDA UDI
- GMDN Term
- Dental digital imaging sensor, intraoral FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.1800 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
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Dental digital imaging sensor, intraoral
WeSensor by Picopack Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K230916 also covers:
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 II | Pending data |
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Manufacturer
- Manufacturer
- Picopack Co., Ltd.
Sources (1)
- FDA UDI 228fa6e4-14ae-438e-8247-4477b7d2d7f2 34 fields · synced May 31, 2026