Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3017220679

FEI Number

3017220679

Entity Name

TNS CO.,LTD

City/State/Country

Geumcheon-gu, Seoul, KR

Establishment Address

402, 406-410, 100, Gasan Digital 1-ro, Geumcheon-gu, Seoul, Geumcheon-gu, Seoul 08590, KR

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device,Repack or Relabel Medical Device

Owner / Operator

TNS CO.,LTD (Owner Number: 10090257)

Owner / Operator Contact Address

1907, 19F, 298, Beotkkot-ro, Geumcheon-gu, Seoul, Daeryung Post Tower 6th, Geumcheon-gu, Seoul, KR-11 08590, KR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K232074

PMA Number

N/A

All Registered Proprietary Names

Serafin® Serafin®

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NXC	Aligner, Sequential	Dental	Class 2	872.5470	2026-01-08
NXC	Aligner, Sequential	Dental	Class 2	872.5470	2024-03-10

Official Correspondent

Won Gun Chang

US Agent Details

David Hyun Jun Paek Email: dpaek.rennes@gmail.com Phone: (818) 9030660

Related Public Records

Same Entity

TNS CO.,LTD

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 3017220679. Last updated year: 2026. Please use registration number 3017220679 when referencing this establishment in official correspondence.