TERA HARZ Hard Denture (8 models)— 510(k) K253681

Name: FDA 510(k) clearance K253681
Creator: U.S. Food and Drug Administration
Published: 2025-11-21

Substantially Equivalent

Graphy, Inc.

FDA 510(k) clearance K253681 for TERA HARZ Hard Denture (8 models), Substantially Equivalent on 2025-11-21. Applicant: Graphy, Inc.. Device class: 2.

Clearance details

Device name as filed: 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)
Applicant: Graphy, Inc.
Product code: Code EBI
Device class: Class 2
Regulation: 21 CFR 872.3760
Advisory panel: Dental
Date received: 2025-11-21
Decision date: 2025-11-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Seoul, KR

Download summary PDF View on FDA.gov ↗

Recent devices under product code EBI

view all

K261802 — Glidewell Denture Base Resin2026-08-27
K261626 — UltraPrint Flexible Denture UV2026-08-13
K262681 — NanoCeram Resin2026-07-31
K262300 — Denture Base Resin V22026-07-08
K261474 — DENTCA Tru Flexible2026-07-01

More clearances from Graphy, Inc.

view all

Adverse events under product code EBI

product code EBI

Other: 1
Total: 1

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.