Identity
- Trade Name
- Panoura X-ERA FDA UDI
- Generic Name
- Stationary panoramic/tomographic dental x-ray system, digital FDA UDI
- Device Name
- Diagnostic imaging equipment for dental treatment. Panoramic imaging & three-dimensional(3D, FOV size x 2) image FDA UDI
- Model / Reference
- Panoura X-ERA NF FDA UDI
- Description
- Diagnostic imaging equipment for dental treatment. Panoramic imaging & three-dimensional(3D, FOV size x 2) image FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04547497759517 FDA UDI
- 510(k) Number
- K182198 FDA UDI
- FDA Product Code
- MUH FDA UDI
- GMDN Term
- Stationary panoramic/tomographic dental x-ray system, digital 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
No
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
No
FDA UDI
Category: Stationary panoramic/tomographic dental x-ray system, digital
Panoura X-ERA by Yoshida Dental Mfg. Co., Ltd., The — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
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
- Yoshida Dental Mfg. Co., Ltd., The
Sources (1)
- FDA UDI 4f349d45-6da9-44a8-90ec-7073a81669d3 36 fields · synced May 29, 2026