Material, Tooth Shade, Resin

Graphy Inc.

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

Pre-market Notification Details

Device IDK202846
510k NumberK202846
Device Name:TERA HARZ
ClassificationMaterial, Tooth Shade, Resin
Applicant Graphy Inc. 1607, Gasan SK V1 Center, 171, Gasan Digital 1-ro, Geumcheon-gu, Seoul,  KR 08503
ContactTae-woo Kim
CorrespondentPeter Chung
Plus Global 300 Atwood Street Pittsburgh,  PA  15213
Product CodeEBF  
CFR Regulation Number872.3690 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-09-25
Decision Date2021-07-15

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