Digital Dental Intra Oral Sensor, EzSensor Classic, EzSensor HD, HDI-P, HDI-S
FDA 510(k) K153060 · Rayence Co., Ltd.
510(k) numberK153060
Submission
- Device name
- Digital Dental Intra Oral Sensor, EzSensor Classic, EzSensor HD, HDI-P, HDI-S
- Applicant
- Rayence Co., Ltd.
Hwaseong-Si, KR - Received
- October 21, 2015
- Decision date
- November 10, 2015
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Digital Dental Intra Oral Sensor, EzSensor Classic, EzSensor HD, HDI-P, HDI-S cleared by the FDA?
Digital Dental Intra Oral Sensor, EzSensor Classic, EzSensor HD, HDI-P, HDI-S (K153060) received a 510(k) decision of Substantially Equivalent on November 10, 2015, 20 days after the submission was received.
What is the product code of K153060?
The FDA product code is MUH – System, X-Ray, Extraoral Source, Digital, a Class II (moderate risk) device regulated under 21 CFR 872.1800.