Cleared Special

Digital Dental Intra Oral Sensor, EzSensor Classic, EzSensor HD, HDI-P, HDI-S

K153060 · Rayence Co., Ltd. · Radiology
Nov 2015
Decision
20d
Days
Class 2
Risk

About This 510(k) Submission

K153060 is an FDA 510(k) clearance for the Digital Dental Intra Oral Sensor, EzSensor Classic, EzSensor HD, HDI-P, HDI-S, a System, X-ray, Extraoral Source, Digital (Class II — Special Controls, product code MUH), submitted by Rayence Co., Ltd. (Hwaseong-Si, KR). The FDA issued a Cleared decision on November 10, 2015, 20 days after receiving the submission on October 21, 2015. This device falls under the Radiology review panel. Regulated under 21 CFR 872.1800.

Submission Details

510(k) Number K153060 FDA.gov
FDA Decision Cleared SESE
Date Received October 21, 2015
Decision Date November 10, 2015
Days to Decision 20 days
Submission Type Special
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code MUH — System, X-ray, Extraoral Source, Digital
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.1800

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