Digital Dental Intra Oral Sensor, EzSensor Classic, EzSensor HD, HDI-P, HDI-S— 510(k) K153060

Name: FDA 510(k) clearance K153060
Creator: U.S. Food and Drug Administration
Published: 2015-11-10

Substantially Equivalent

Rayence Co., Ltd.

FDA 510(k) clearance K153060 for Digital Dental Intra Oral Sensor, EzSensor Classic, EzSensor HD, HDI-P, HDI-S, Substantially Equivalent on 2015-11-10. Applicant: Rayence Co., Ltd.. Device class: 2.

Clearance details

Applicant: Rayence Co., Ltd.
Product code: Code MUH
Device class: Class 2
Regulation: 21 CFR 872.1800
Advisory panel: Dental
Date received: 2015-10-21
Decision date: 2015-11-10
Decision: Substantially Equivalent
Clearance type: Special
Location: Hwaseong-Si, KR

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.