Cleared Traditional

TERA HARZ

K202846 · Graphy, Inc. · Dental
Jul 2021
Decision
293d
Days
Class 2
Risk

About This 510(k) Submission

K202846 is an FDA 510(k) clearance for the TERA HARZ, a Material, Tooth Shade, Resin (Class II — Special Controls, product code EBF), submitted by Graphy, Inc. (Seoul, KR). The FDA issued a Cleared decision on July 15, 2021, 293 days after receiving the submission on September 25, 2020. This device falls under the Dental review panel. Regulated under 21 CFR 872.3690.

Submission Details

510(k) Number K202846 FDA.gov
FDA Decision Cleared SESE
Date Received September 25, 2020
Decision Date July 15, 2021
Days to Decision 293 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code EBF — Material, Tooth Shade, Resin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.3690

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