Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3027641453

FEI Number

3027641453

Entity Name

HERIBIO INC.

City/State/Country

Seoul, KR

Establishment Address

5F, 354, Gangnam-daero, Gangnam-gu, Seoul 06242, KR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

HERIBio Inc. (Owner Number: 10088425)

Owner / Operator Contact Address

5F, 354, Gangnam-daero, Gangnam-gu, Seoul, KR-11 06242, KR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

HERi Implant Crown HERi Denture HERi Crown&Bridge

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NSP	Restoration, Porcelain	Unknown	Class N	N/A	2023-07-20
NSL	Dentures, Full	Unknown	Class N	N/A	2023-07-20
NSN	Restoration, Resin, Crown And Bridge	Unknown	Class N	N/A	2023-07-20

Official Correspondent

YoungJi Lee

US Agent Details

Huichao Lee Business: SMB USA LLC. Email: info@smbusa.com Phone: (734) 6297552

Related Public Records

Same Entity

HERIBio Inc.

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

View Entity Profile →

Similar Registrations

Registration Number	Establishment Name	Location
3021389380	ABL DENTAL SOLUTIONS S.A.S	Envigado Antioquia, CO
3005310881	DIGITAL DENTAL FUSION KOREA	Seoul, KR
3021241833	LEAGUE DENTAL TECHNOLOGY LTD	Shenzhen Guangdong, CN
3005952241	ACER DENTALLAB CO LIMITED	HONGKONG, HK
3007268434	ADS DENTAL LAB LTD.	Shenzhen Guangdong, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3027641453. Last updated year: 2026. Please use registration number 3027641453 when referencing this establishment in official correspondence.