Manufacturer registered with FDA
Graphy, Inc.
Seoul, South Korea. Lists 6 dental device types with FDA across 1 registered establishment, and holds 6 510(k) clearances as applicant.
- Device types listed
- 6
- Brands and models
- 9
- 510(k) clearances
- 62021–2025
- Markets registered in
- 959 registrations outside the US
- Establishments
- 1South Korea
510(k) clearances per year, 2007–2026
Registered in 9 markets
Where regulators' registries name Graphy, Inc. as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | Graphy, Inc. | 6 clearances | 2021–2025 | Below |
| European Union | EUDAMED | Manufacturer | Graphy Inc. | 42 | — | Pure Global AI |
| Australia | TGA | Manufacturer | Graphy Inc | 4 | 2026–2026 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | Graphy Inc. | 4 | 2023–2024 | Pure Global AI |
| Brazil | ANVISA | Manufacturer | GRAPHY INC. | 2 | 2026–2026 | Pure Global AI |
| Canada | Health Canada | Registration holder | GRAPHY INC. | 2 | 2025–2025 | Pure Global AI |
| Serbia | ALIMS | Manufacturer | Graphy Inc. | 2 | 2024–2024 | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | Graphy Inc. | 2 | — | Pure Global AI |
| Israel | AMAR | Manufacturer | Graphy Inc. | 1 | — | Pure Global AI |
Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026
Devices listed with FDA
What Graphy, Inc. currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Resin Tooth Shade MaterialEBF · Class 2 | Dental composites | Maker | TERA HARZTera Harz II | 2021 |
| Resin Temporary Crown and BridgeEBG · Class 2 | Temporary crown & bridge materials | Maker | TERA HARZTera Harz II | 2021 |
| Rebasing Repairing Relining Denture ResinEBI · Class 2 | Denture resins & teeth | Maker | TERA HARZ DENTURETera Harz Hard Denture | 2022 |
| Preformed Tooth PositionerKMY · Class 1 | Retainers, expanders & headgear | Maker | Tera Tainer (Model : TA-83) | 2026 |
| Endosseous Dental Implant AccessoriesNDP · Class 1 | Implant instruments & surgical kits | Maker | TERA HARZ SG | 2019 |
| Sequential AlignerNXC · Class 2 | Clear aligners | Maker | TERA HARZ CLEAR (TC-85DAC, TR-07, TA-28) | 2024 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
510(k) clearances
Clearances on which FDA names Graphy, Inc. as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 21 Nov 2025 | 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) | EBI Rebasing Repairing Relining Denture Resin |
| 5 Mar 2024 | K240597 | TERA HARZ CLEAR | NXC Sequential Aligner |
| 1 Nov 2023 | K233502 | TERA HARZ II | EBF Resin Tooth Shade Material |
| 3 Nov 2022 | K223355 | Tera Harz Clear | NXC Sequential Aligner |
| 11 Aug 2022 | K222414 | TERA HARZ DENTURE | EBI Rebasing Repairing Relining Denture Resin |
| 15 Jul 2021 | K202846 | TERA HARZ | EBF Resin Tooth Shade Material |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| Graphy Inc.FDA reg. 3015302693 | Seoul, South Korea | Foreign exporter, Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10061702). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.