Tera Harz Clear

Aligner, Sequential

Graphy Inc.

The following data is part of a premarket notification filed by Graphy Inc. with the FDA for Tera Harz Clear.

Pre-market Notification Details

Device IDK223355
510k NumberK223355
Device Name:Tera Harz Clear
ClassificationAligner, Sequential
Applicant Graphy Inc. 603, #617, Ace Gasan Forhu, 225, Gasan Digital 1-ro, Geumcheon-gu, Seoul,  KR 08503
ContactMoon Soo Part
CorrespondentDave Yungvirt
THIRD PARTY REVIEW GROUP, LLC 25 Independence Blvd Warren,  NJ  07059
Product CodeNXC  
CFR Regulation Number872.5470 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2022-11-02
Decision Date2022-11-03

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