# Graphy, Inc.

- Location (FDA's records): Seoul, KR
- FDA decisions: 6 (2021–2025): 6 510(k) clearances
- Product codes: EBI (2), EBF (2), NXC (2)
- 510(k) review time since 2016: median 1 days, against 121 for FDA's reviews in the same codes and years (5 of 6 faster)
- Predicates its devices cite: 5 (1 its own); citations of its devices by later devices: 8 (1 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Blue Sky Bio, LLC: 2 (https://510kreport.com/company/blue-sky-bio)
- Dentca, Inc.: 1 (https://510kreport.com/company/dentca)
- Bego Bremer Goldschlägerei Wilh. Herbst GmbH & Co. KG: 1 (https://510kreport.com/company/bego-bremer-goldschlagerei-wilh-herbst)

## Firms that cite its devices most
- Saremco Dental AG: 1 (https://510kreport.com/company/saremco-dental)
- Arum Dentistry Co., Ltd.: 1 (https://510kreport.com/company/arum-dentistry)
- Detax GmbH & Co. KG: 1 (https://510kreport.com/company/detax)
- C.E.I.B.Med: 1 (https://510kreport.com/company/ceibmed)
- Park Dental Research Corp.: 1 (https://510kreport.com/company/park-dental-research)
- Ods Co., Ltd.: 1 (https://510kreport.com/company/ods)
- Dws, Inc.: 1 (https://510kreport.com/company/dws)

## Its most-cited devices
- K202846: Tera Harz (2021), cited by 5
- K223355: Tera Harz Clear (2022), cited by 2
- K233502: Tera Harz II (2023), cited by 1

## Recent decisions
- K253681: 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) (Nov 21, 2025)
- K240597: Tera Harz Clear (Mar 5, 2024)
- K233502: Tera Harz II (Nov 1, 2023)
- K223355: Tera Harz Clear (Nov 3, 2022)
- K222414: Tera Harz Denture (Aug 11, 2022)
- K202846: Tera Harz (Jul 15, 2021)

Source page: https://510kreport.com/company/graphy