Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010551934

FEI Number

3010551934

Entity Name

SAEYANG CO., LTD.

City/State/Country

DALSEO-GU Daegu, KR

Establishment Address

(Galsan-Dong), 348 SEONGSEO-RO, DALSEO-GU Daegu 42697, KR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

SAEYANG CO., LTD. (Owner Number: 10086948)

Owner / Operator Contact Address

(Galsan-Dong), 348 SEONGSEO-RO, DALSEO-GU, KR-27 42697, KR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K123582

PMA Number

N/A

All Registered Proprietary Names

PRO M CLASS Ki-20 Endo A Class CanalPro CL2

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EKX	Handpiece, Direct Drive, Ac-Powered	Dental	Class 1	872.4200	2022-12-26
EBW	Controller, Foot, Handpiece And Cord	Dental	Class 1	872.4200	2022-12-26
EKX	Handpiece, Direct Drive, Ac-Powered	Dental	Class 1	872.4200	2022-12-26

Official Correspondent

JUNG PIL SHIN

US Agent Details

Jung Ryun Ahn Business: KMC USA, Inc Email: kmc.usa@kmcerti.com Phone: (646) 3576058

Related Public Records

Same Entity

SAEYANG CO., LTD.

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
K241065	Dentis Co., Ltd.	ChecQ (AC100)	2025-03-21
K040153	Indigenous Peoples Technology and Education Center	I-TEC PORTABLE DENTAL OPERATORY	2004-05-21

Similar Registrations

Registration Number	Establishment Name	Location
9614866	ADVANCED TECHNOLOGY RESEARCH S.R.L.	PISTOIA, IT
3001082453	SWEDEN & MARTINA S.P.A.	Due Carrare Padova, IT
3025873468	WELL MEDICAL	Incheon, KR
3017604	ASEPTICO, INC.	WOODINVILLE, WA, US
9611253	NAKANISHI INC.	Kanuma Tochigi, JP

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010551934. Last updated year: 2026. Please use registration number 3010551934 when referencing this establishment in official correspondence.