Cleared Traditional

TERA HARZ Hard Denture (THD-C-500); TERA HARZ Hard Denture (THD-C-1000); TERA HARZ Hard Denture (THD-LP-500); TERA HARZ Hard Denture (THD-LP-1000); TERA HARZ Hard Denture (THD-P-500); TERA HARZ Hard Denture (THD-P-1000); TERA HARZ Hard Denture (THD-CP-500); TERA HARZ Hard Denture (THD-CP-1000)

K253681 · Graphy, Inc. · Dental

Nov 2025

Decision

—

Days

Class 2

Risk

About This 510(k) Submission

K253681 is an FDA 510(k) clearance for the TERA HARZ Hard Denture (THD-C-500); TERA HARZ Hard Denture (THD-C-1000); TERA HARZ Hard Denture (THD-LP-500); TERA HARZ Hard Denture (THD-LP-1000); TERA HARZ Hard Denture (THD-P-500); TERA HARZ Hard Denture (THD-P-1000); TERA HARZ Hard Denture (THD-CP-500); TERA HARZ Hard Denture (THD-CP-1000), a Resin, Denture, Relining, Repairing, Rebasing (Class II — Special Controls, product code EBI), submitted by Graphy, Inc. (Seoul, KR). The FDA issued a Cleared decision on November 21, 2025. This device falls under the Dental review panel. Regulated under 21 CFR 872.3760.

Submission Details

510(k) Number	K253681 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 21, 2025
Decision Date	November 21, 2025
Days to Decision	—
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Summary PDF