EzSensor Classic, EzSensor HD, HDI-P, HDI-S Digital Dental Intra Oral Sensor
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K153060 FDA 510(k)
- FDA Product Code
- MUH FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 872.1800 FDA 510(k)
- Regulation Number
- 872.1800 FDA 510(k)
- Advisory Committee
- Dental FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The EzSensor Classic, EzSensor HD, HDI-P, and HDI-S are digital intraoral sensors designed for capturing high-resolution radiographic images of dental structures. These devices utilize CMOS sensor technology to convert X-ray photons into electronic signals, enabling precise imaging for diagnostic purposes in dentistry.
The sensors connect via USB to a computer for image processing, storage, and analysis using compatible software such as Easydent or EzDent-i. They are classified under product code MUH as Class II devices under special controls, with FDA 510(k) clearance (K153060) and MDD authorization. The devices are intended for single-use or reusable applications, depending on manufacturer guidelines, and are regulated under the EU Medical Device Directive (MDD) and U.S. FDA requirements.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Digital Dental Intra Oral Sensor, EzSensor Classic, EzSensor HD, HDI-P ..., K153060 - Digital Dental Intra Oral Sensor | FDA 510 (k), Digital Dental Intra Oral Sensor, EzSensor Classic… - FDA.report
Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K153060 | Class II | Active |
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Manufacturer
- Manufacturer
- Rayence Co., Ltd.
Sources (2)
- FDA 510(k) K153060 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 18, 2026