SILDENT

Material, Impression

HRS CO., LTD.

The following data is part of a premarket notification filed by Hrs Co., Ltd. with the FDA for Sildent.

Pre-market Notification Details

Device IDK132869
510k NumberK132869
Device Name:SILDENT
ClassificationMaterial, Impression
Applicant HRS CO., LTD. 216-5 BLOCK 6 CHOOPAL INDUSTRIAL COMPLEX 394-1 CHOOPAL-RI Pyongtaek,  KR 451-805
ContactJae-hyeon Choi
CorrespondentJae-hyeon Choi
HRS CO., LTD. 216-5 BLOCK 6 CHOOPAL INDUSTRIAL COMPLEX 394-1 CHOOPAL-RI Pyongtaek,  KR 451-805
Product CodeELW  
CFR Regulation Number872.3660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-09-13
Decision Date2014-06-19
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
08809746990048 K132869 000
08809746990031 K132869 000
08809746990024 K132869 000
18809746990014 K132869 000

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