Cleared Special

Digital Dental Intra Oral Sensor, EzSensor Smart

K150797 · Rayence Co., Ltd. · Radiology
May 2015
Decision
36d
Days
Class 2
Risk

About This 510(k) Submission

K150797 is an FDA 510(k) clearance for the Digital Dental Intra Oral Sensor, EzSensor Smart, 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 May 1, 2015, 36 days after receiving the submission on March 26, 2015. This device falls under the Radiology review panel. Regulated under 21 CFR 872.1800.

Submission Details

510(k) Number K150797 FDA.gov
FDA Decision Cleared SESE
Date Received March 26, 2015
Decision Date May 01, 2015
Days to Decision 36 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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