Digital Dental Intra Oral Sensor, EzSensor Smart
FDA 510(k) K150797 · Rayence Co., Ltd.
510(k) numberK150797
Submission
- Device name
- Digital Dental Intra Oral Sensor, EzSensor Smart
- Applicant
- Rayence Co., Ltd.
Hwaseong-Si, KR - Received
- March 26, 2015
- Decision date
- May 1, 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 Smart cleared by the FDA?
Digital Dental Intra Oral Sensor, EzSensor Smart (K150797) received a 510(k) decision of Substantially Equivalent on May 1, 2015, 36 days after the submission was received.
What is the product code of K150797?
The FDA product code is MUH – System, X-Ray, Extraoral Source, Digital, a Class II (moderate risk) device regulated under 21 CFR 872.1800.