510(k) Report

FDA applicant

Graphy, Inc.

Seoul, KR6 decisions2021–20250 recalls

FDA records 6 decisions for Graphy, Inc. (Seoul, KR) from 2021 to 2025: 6 510(k) clearances. Most are in product codes EBI (Resin, Denture, Relining, Repairing, Rebasing) and EBF (Material, Tooth Shade, Resin). Since 2016 its 510(k)s took a median of 1 days from receipt to decision, against 121 for FDA’s reviews in the same codes and years. Its devices cite 5 predicates, 1 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, dental panel, where it files most

How often FDA has decided Graphy, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2021: 12022: 22023: 12024: 12025: 1
2021high 2 (2022) · low 1 (2021)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2021.

FIG. 1 — Graphy, Inc. by year, 2021–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Graphy, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • EBIResin, Denture, Relining, Repairing, Rebasing2decisions
  • EBFMaterial, Tooth Shade, Resin2decisions
  • NXCAligner, Sequential2decisions

How long do its 510(k) reviews take?

Since 2016, its 6 510(k)s took a median of 1 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 121 days; 5 of its 6 were faster than that.

Whose devices does it build on?

Its devices cite 5 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 8 times; 1 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K202846Tera HarzGraphy, Inc. · 20215cite it
  • K223355Tera Harz ClearGraphy, Inc. · 20222cite it
  • K233502Tera Harz IIGraphy, Inc. · 20231cites it

What has FDA decided for it lately?

  • K253681TERA HARZ Hard Denture (THD-C-500); TERA HARZ Hard Denture (THD-C-1000); TERA HARZ Hard Denture…Graphy, Inc. · 2025
  • K240597Tera Harz ClearGraphy, Inc. · 2024
  • K233502Tera Harz IIGraphy, Inc. · 2023
  • K223355Tera Harz ClearGraphy, Inc. · 2022
  • K222414Tera Harz DentureGraphy, Inc. · 2022
  • K202846Tera HarzGraphy, Inc. · 2021

All 6 as Graphy, Inc. →