Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3031570301

FEI Number

3031570301

Entity Name

ARCREAL INC.

City/State/Country

Seoul, KR

Establishment Address

Units 1206~1210, 12F, Gasan A1 Tower, 205-27 Gasan digital 1-ro, Geumcheon-gu, Seoul 08503, KR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Arcreal Inc. (Owner Number: 10091050)

Owner / Operator Contact Address

Units 1206~1210, 12F, Gasan A1 Tower, 205-27, Gasan digital 1-ro, Geumcheon-gu, Seoul, KR-NOTA 08503, KR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Arcscan Intraoral Scanner ARC-IOS100, ARC-IOS100H

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NOF	System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations	Dental	Class 2	872.3661	2024-06-22

Official Correspondent

No official correspondent registered.

US Agent Details

Charles Mack Business: IRC USA Email: ircfda@gmail.com Phone: (931) 6254938

Related Public Records

Same Entity

Arcreal Inc.

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

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3031570301. Last updated year: 2026. Please use registration number 3031570301 when referencing this establishment in official correspondence.