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

System, X-ray, Extraoral Source, Digital

RAYENCE CO., LTD

The following data is part of a premarket notification filed by Rayence Co., Ltd with the FDA for Digital Dental Intra Oral Sensor, Ezsensor Classic, Ezsensor Hd, Hdi-p, Hdi-s.

Pre-market Notification Details

Device IDK153060
510k NumberK153060
Device Name:Digital Dental Intra Oral Sensor, EzSensor Classic, EzSensor HD, HDI-P, HDI-S
ClassificationSystem, X-ray, Extraoral Source, Digital
Applicant RAYENCE CO., LTD 14, SAMSUNG 1-RO, 1-GIL Hwaseong-si,  KR 445-170
ContactKevin Kim
CorrespondentDave Kim
MTECH GROUP 8310 BUFFALO SPEEDWAY Houston,  TX  77025
Product CodeMUH  
CFR Regulation Number872.1800 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-10-21
Decision Date2015-11-10
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00858475006030 K153060 000

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