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 Gadolinium Oxysulfide (Gd2O2S:Tb), and there is no filter layer in these models. The dimension of this sensor is 43.0 mm × 33.0 mm× 12.0 mm. FDA UDI
- Model / Reference
- G350A FDA UDI
- Description
- The WeSensor is an intraoral digital x-ray sensor. This model uses a scintillator made from Gadolinium Oxysulfide (Gd2O2S:Tb), and there is no filter layer in these models. The dimension of this sensor is 43.0 mm × 33.0 mm× 12.0 mm. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08809840720008 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 343cc3cf-4e12-4cd0-9705-5281ea8fa91d 34 fields · synced Jun 8, 2026