Data / Medical devices / South Korea / Graphy Inc.

Graphy Inc.: FDA-registered device maker in Seoul, South Korea, 5 510(k) clearances

Name: Graphy Inc. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Graphy Inc. is registered with the FDA (registration 3015302693) in Seoul, South Korea. It lists 7 device types. The FDA files 5 510(k) clearances under its listings, the newest dated November 21, 2025. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3015302693
Address: #601, #603, #617, Ace Gasan Forhu, 225, Gasan digital 1-ro, Geumcheon-gu, Seoul, South Korea, 08501
Owner or operator: Graphy, Inc. (10061702)
Roles: Exporter to the US, Manufacturer
First device listed: November 11, 2019
Registered through: 2026
Brand names listed: TERA HARZ, TERA HARZ CLEAR (TC-85DAC, TR-07, TA-28), TERA HARZ DENTURE, TERA HARZ II, TERA HARZ SG, Tera Harz, Tera Harz Clear (TC-85DAC, TR-07, TA-28), Tera Harz Denture and more

Devices it lists

Device	Product code	Class	Role	Source
Accessories, Implant, Dental, Endosseous	NDP	1	Exporter to the US, Manufacturer	accessdata.fda.gov
Aligner, Sequential	NXC	2	Exporter to the US, Manufacturer	accessdata.fda.gov
Crown And Bridge, Temporary, Resin	EBG	2	Exporter to the US, Manufacturer	accessdata.fda.gov
Material, Tooth Shade, Resin	EBF	2	Exporter to the US, Manufacturer	accessdata.fda.gov
Positioner, Tooth, Preformed	KMY	1	Exporter to the US, Manufacturer	accessdata.fda.gov
Protector, Dental	BRW	1	Exporter to the US, Manufacturer	accessdata.fda.gov
Resin, Denture, Relining, Repairing, Rebasing	EBI	2	Exporter to the US, Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
November 21, 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	Substantially Equivalent	Graphy, Inc.	accessdata.fda.gov
March 5, 2024	K240597	TERA HARZ CLEAR	NXC	Substantially Equivalent	Graphy, Inc.	accessdata.fda.gov
November 1, 2023	K233502	TERA HARZ II	EBF	Substantially Equivalent	Graphy, Inc.	accessdata.fda.gov
August 11, 2022	K222414	TERA HARZ DENTURE	EBI	Substantially Equivalent	Graphy, Inc.	accessdata.fda.gov
July 15, 2021	K202846	TERA HARZ	EBF	Substantially Equivalent	Graphy, Inc.	accessdata.fda.gov

Compare with other makers

Updated November 21, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.