Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3015302693

FEI Number

3015302693

Entity Name

Graphy Inc.

City/State/Country

Seoul, KR

Establishment Address

#601, #603, #617, Ace Gasan Forhu, 225, Gasan digital 1-ro, Geumcheon-gu, Seoul 08501, KR

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device,Manufacture Medical Device

Owner / Operator

Graphy, Inc. (Owner Number: 10061702)

Owner / Operator Contact Address

#603, #617 Ace Gasan Forhu, 225, Gasan digital 1-ro, Geumcheon-gu, Seoul, KR-11 08501, KR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Tera Tainer (Model : TA-83) TERA HARZ II TERA HARZ TeraFlex Guard (Model : TeraFlex) Tera Harz Guard (Model : TE-151)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KMY	Positioner, Tooth, Preformed	Dental	Class 1	872.5525	2026-05-08
EBG	Crown And Bridge, Temporary, Resin	Dental	Class 2	872.3770	2023-11-21
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2023-11-21
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2021-07-16
EBG	Crown And Bridge, Temporary, Resin	Dental	Class 2	872.3770	2021-07-16
BRW	Protector, Dental	Anesthesiology	Class 1	868.5820	2020-12-15

Official Correspondent

Un-seob Sim

US Agent Details

HUICHAO LEE Business: SMB USA LLC. Email: info@smbusa.com Phone: (734) 3671285

Related Public Records

Same Entity

Graphy, Inc.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K952662	Jeneric/Pentron, Inc.	COMP=FLOW	1995-08-28
K171147	Bisco, Inc.	REVEAL Bulk	2017-08-04
K770922	Espe GmbH (Us)	DENTAL RESTORATIVE IN CAPSULES	1977-06-01
K153476	Kuraray Noritake Dental, Inc.	KATANA AVENCIA Block	2016-08-23

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0028-2020	Voco GmbH Anton-Flettner-Str. 1-3 Cuxhaven Germany	2	Grandio SO Heavy Flow Caps, Color A3 - Product Usage: Filling minimally invasive cavities of all classes - Filling small class I cavities and extended fissure sealing - Filling class II - V cavities including V-shaped defects and cervical caries - Blocking out undercuts - Lining or coating cavities - Repairing fillings and veneers - Luting translucent prosthetic pieces (e.g., full ceramic crowns, etc.).

Similar Registrations

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3021741991	FOREST-ONE CO.,LTD.	Funabashi Chiba, JP
2086043	PAC-DENT INC.	Brea, CA, US
1000118628	FIVE STAR ORTHODONTIC LABORATORY & SUPPLY, INC.	Denton, TX, US
1815540	TP ORTHODONTICS, INC.	LA PORTE, IN, US
3010279788	Formlabs Inc.	Somerville, MA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3015302693. Last updated year: 2026. Please use registration number 3015302693 when referencing this establishment in official correspondence.