Digital Dental Intra Oral Sensor, EzSensor Soft, EzSensor Bio— 510(k) K143753

Name: FDA 510(k) clearance K143753
Creator: U.S. Food and Drug Administration
Published: 2015-03-10

Substantially Equivalent

Rayence Co., Ltd.

FDA 510(k) clearance K143753 for Digital Dental Intra Oral Sensor, EzSensor Soft, EzSensor Bio, Substantially Equivalent on 2015-03-10. 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: 2014-12-31
Decision date: 2015-03-10
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.