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Medical DevicesKOSDAQ 31806024 approvals

Graphy Inc.

Official website

Medical device company developing Tera Harz Clear shape-memory 3D printing material and the Shape Memory Aligner (SMA).

As of 2026-10-10, Graphy Inc. has 18 Korean MFDS device approvals, 6 US FDA clearances/approvals, 11 PubMed-indexed papers on record (counted by the MAA Company Index from its own matching of public databases).

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Market cap

Business overview

Source: DART corporate disclosure

Founded in 2017 and listed on KOSDAQ in 2025, Graphy Inc. is a medical device company. Its shape-memory 3D printing material Tera Harz Clear underlies the Shape Memory Aligner (SMA), alongside Tera Harz Denture, Tera Harz SG, and Tera Harz Cure. From April 2023 to December 2027, it develops biocompatible biliary stent materials under a KRW 970 million government-funded project.

Products & technology

  • Tera Harz Clear
  • Tera Harz
  • Tera Harz Denture
  • Tera Harz SG
  • Tera Harz Guard
  • S-Plastic
  • Shape Memory Aligner (SMA)
  • Tera Harz Cure
  • Tera Harz Spinner
  • Tera Harz Smart Robot

Regulatory approvals

data.go.kr · openFDA

18 Korean MFDS device approvals · 2020–2026 / 6 US FDA 510(k) · 2021–2025

  • MFDSresin, crown & bridge2026-09-07
    Product approval · Class 2제인 26-4819 호
  • MFDSappliance, orthodontic, resin2026-05-08
    Product approval · Class 2제인 26-4413 호
  • MFDSresin, crown & bridge2026-01-09
    Product approval · Class 2제인 26-4026 호
  • MFDSmaterial, denture, glazing/hardening2026-01-09
    Product approval · Class 2제인 26-4025 호
  • FDATERA 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)2025-11-21
    510(k) · TraditionalDentalK253681
  • MFDSappliance, orthodontic, resin2024-04-15
    Product approval · Class 2제인 24-387 호
  • FDATERA HARZ CLEAR2024-03-05
    510(k) · SpecialDentalK240597
  • FDATERA HARZ II2023-11-01
    510(k) · TraditionalDentalK233502
  • MFDSGuard for the prevention of bruxism2023-04-28
    Product approval · Class 1제신 23-748 호
  • MFDSresin, crown & bridge2023-04-21
    Product approval · Class 2제인 23-4658 호
  • FDATera Harz Clear2022-11-03
    510(k) · TraditionalDentalK223355
  • FDATERA HARZ DENTURE2022-08-11
    510(k) · TraditionalDentalK222414
Show 12 more
  • MFDSresin, denture, light-curing2022-06-13
    Product approval · Class 2제인 22-4443 호
  • MFDSresin, crown & bridgeRevoked2021-12-30
    Product approval · Class 2제인 21-5085 호
  • MFDSresin, denture, light-curingRevoked2021-12-30
    Product approval · Class 2제인 21-5084 호
  • MFDSappliance, orthodontic, resin2021-11-10
    Product approval · Class 2제인 21-4949 호
  • FDATERA HARZ2021-07-15
    510(k) · TraditionalDentalK202846
  • MFDSSplint, mouldableRevoked2021-03-29
    Product approval · Class 1제신 21-419 호
  • MFDSresin, denture, light-curing2020-12-24
    Product approval · Class 2제인 20-5151 호
  • MFDSImplant, surgical, guide for medical use2020-04-16
    Product approval · Class 2제인 20-4284 호
  • MFDSGuard for the prevention of bruxism2020-03-13
    Product approval · Class 1제신 20-332 호
  • MFDSresin, impression tray2020-03-12
    Product approval · Class 1제신 20-328 호
  • MFDSappliance, orthodontic, resin2020-02-11
    Product approval · Class 2제인 20-4106 호
  • MFDSresin, crown & bridge2020-02-04
    Product approval · Class 2제인 20-4082 호

R&D and key agreements

Source: DART corporate disclosure

모델 소재 개발 · 2017.01~2017.12, 상용화 완료 · Developed and commercialized S-100M.

투명교정장치용 소재 개발 · 2017.06~2019.02, 상용화 완료 · Developed and commercialized TC-85.

ABS 유사 소재 개발 · 2017.06~2018.05, 상용화 완료 · Developed and commercialized S-100.

디지털 깁스 제작을 위한 3D프린팅용 광경화수지 신소재 개발 · 2018.06~2019.03, 개발 완료 · Government grant KRW 55 million; developed Tera Harz Digital Gips.

증강현실과 인공지능을 이용한 올온엑스임플란트 식립 지원 및 치아보철 솔루션 개발 · 2019.06~2020.12, 상용화 완료 · Government grant KRW 100 million; developed and commercialized SG-100 and THD.

굴곡강도 120MPa 이상 개인 맞춤형 부목 치료를 위한 3D프린팅 신소재 제품화 · 2020.05~2021.03, 상용화 완료 · Government grant KRW 400 million; developed and commercialized Tera Harz Digital Gips.

굴곡강도 200MPa 이상 개인 맞춤형 의치 치료를 위한 3D프린팅 신소재개발 · 2020.12~2022.12, 상용화 완료 · Government grant KRW 400 million; developed and commercialized TC-80, THD, and TFDH.

3D프린터용 고기능성 Smart Materials 기술 · 2020.11~2021.03, 개발 완료 · Government grant KRW 112 million; developed a 3D printing elastic material.

DLP 기반 자동차 지그 고정구용 고내열성, 고강도 광경화성 레진개발 · 2020.09~2021.06, 개발 완료 · Government grant KRW 100 million; developed a 3D printing automotive jig material.

모델 소재 개발 · 2020.09~2021.06, 상용화 완료 · Developed and commercialized S-200M.

3D프린팅 기반 신체 맞춤형 자전거 안장 대량 제조기술 및 서비스 플랫폼 개발 · 2021.04~2022.12, 개발 완료 · Government grant KRW 166 million; developed a 3D printing bicycle saddle material.

개인맞춤형 영구보철을 위한 3D프린팅 나노복합 신소재 개발 · 2021.04~2023.01, 상용화 완료 · Government grant KRW 500 million; developed and commercialized BR-23.

정전기 방지가 가능한 커스터마이징 스마트 그리퍼용 이중강성 소재 개발 · 2021.04~2022.12, 개발 완료 · Government grant KRW 200 million; developed a 3D printing gripper material.

질소발생기를 포함한 고광량 경화기 개발 · 2021.04~2021.11, 상용화 완료 · Developed and commercialized Tera Harz Cure (THC).

3D프린팅용 플렉시블 덴처 광경화성 소재 개발 · 2021.09~2023.08, 상용화 완료 · Government grant KRW 400 million; developed and commercialized TFDH.

형상기억 투명교정장치 소재(신소재) 개발 · 2022.02~2024.05, 상용화 완료 · Developed and commercialized TR-07.

원심분리형 탈레진기 개발 · 2022.03~2023.09, 상용화 완료 · Developed and commercialized Tera Harz Spinner (THSP).

형상기억 투명교정장치 디자인 셋업 소프트웨어(DAD) 개발 · 2022.04~2024.02, 상용화 완료 · Developed and commercialized the DAD design setup software.

형상기억 투명교정장치 소재(신소재) 개발 · 2022.06~2024.05, 상용화 완료 · Developed and commercialized TA-28.

환자맞춤형 직접출력 담도 스텐트-치아교정장치용 심바이오틱 생체적합성 의료기기소재 및 제품화 기술 개발 · 2023.04~2027.12, 개발중 · Government grant KRW 970 million; developing materials for SMA and biliary stents.

Aligner 초음파 세척기 · 2023.08~2023.10, 상용화 완료 · Outsourced development and commercialized Tera Harz Care (THCA).

구강스캔 데이터의 치아자동분할 AI솔루션 · 2024.05~2024.11, 개발 완료 · Government grant KRW 300 million; developed DAD and DAS.

세라믹보철소재 개발 (저함량) · 2024.01~현재, 개발중 · R-191 under development.

Aligner 생산을 위한 로봇시스템 개발 · 2024.01~현재 · Development related to Tera Harz Smart Robot (THSR); source text is truncated so exact status is unclear.

Key disclosures

KRX KIND via OpenDART

Publications

PubMed · affiliation-matched
Show 1 more publications

Patents

KIPRIS · applicant-matched
Show 74 more patents

AI reads

MAA server logs · IP-verified
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Last 7 days
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Last 30 days
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Measured since Aug 27, 2026 · 4 AI engines · last read Oct 9, 2026

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Companies approved for the same productsMedical Devices

Ranked by how many MFDS product categories overlap. Not a ranking — a pointer to where to look.

DIO Corporation5 shared

DIO Corporation, established in 1988 and listed on KOSDAQ in 2000, manufactures and sells dental implants.

DENTIS CO.,LTD4 shared

Founded in 2016 and listed on KOSDAQ in 2017, DENTIS manufactures dental implants, medical LED lighting, and dental 3D printers.

SHINHUNG CO.,LTD4 shared

Founded in 1964 and KOSPI-listed in 1991, Shinhung manufactures and distributes dental equipment and materials.

Ray Co., Ltd.2 shared

KOSDAQ-listed dental medical device company offering the RAYSCAN digital diagnostic system and RAYDENT digital treatment solutions.

T&R Biofab Co., Ltd1 shared

Founded in 2013 and KOSDAQ-listed in 2018, T&R Biofab commercializes 3D bioprinting systems, bioinks, and biodegradable scaffolds.

YUHAN CORPORATION1 shared

Founded in 1926 and listed on the KOSPI in 1962, Yuhan Corporation is a comprehensive pharmaceutical company known for its innovative drug Leclaza.

INTEROJO CO. LTD.100

Interojo, founded 2000 and KOSDAQ-listed 2010, manufactures contact lenses under its Clalen brand domestically and via OEM/ODM overseas.

MITECH CO.,LTD.100

MITECH CO.,LTD., founded in 1991 and listed on KOSDAQ in 2018, makes non-vascular stents and distributes Fujifilm endoscopy equipment.

JETEMA Co.,Ltd.90

Founded 2009, listed on KOSDAQ in 2019, JETEMA develops hyaluronic acid fillers, botulinum toxin biopharmaceuticals, and lifting threads.

Corentec Co., Ltd.85

Founded in 2000 and KOSDAQ-listed in 2013, Corentec makes artificial joints; hip and knee implants exceed 85% of revenue.

NanoenTek,Inc.85

Founded in 1987 and listed on KOSDAQ in 2000, NanoenTek develops Lab-On-a-Chip in-vitro diagnostic devices and life science instruments.

SEJONG MEDICAL Co.Ltd.,85

Founded in 2010 and KOSDAQ-listed in 2018, Sejong Medical manufactures laparoscopic surgical instruments.

Sources and updates

Counts on this page are not company-reported figures. MAA matched records from DART, the Korean MFDS, the US FDA, ClinicalTrials.gov, PubMed and KIPRIS to this company itself, by business registration number or registered name, never by name similarity. They may differ from figures the company publishes.

Company basics
Korea Exchange · DART
Business content
Compiled from disclosure filings
Approvals & clinical trials
Korean MFDS (data.go.kr) · US FDA openFDA — updated weekly
Key disclosures
KRX KIND via OpenDART exchange filings — updated daily
Global clinical trials
ClinicalTrials.gov (US NIH) — sponsor-matched, updated weekly
Financials
DART corporate disclosure filings — annual
Publications
PubMed (US National Library of Medicine) — affiliation-matched, updated daily
Patents
KIPRIS (Korea Institute of Patent Information) — applicant-matched, updated monthly
AI reads
Our server logs, IP-verified every 6 hours
AI visibility
Measured 2026-10-01

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