Cleared Traditional

TERA HARZ II

K233502 · Graphy, Inc. · Dental
Nov 2023
Decision
1d
Days
Class 2
Risk

About This 510(k) Submission

K233502 is an FDA 510(k) clearance for the TERA HARZ II, 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 November 1, 2023, 1 days after receiving the submission on October 31, 2023. This device falls under the Dental review panel. Regulated under 21 CFR 872.3690.

Submission Details

510(k) Number K233502 FDA.gov
FDA Decision Cleared SESE
Date Received October 31, 2023
Decision Date November 01, 2023
Days to Decision 1 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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