Data / Medical devices / South Korea / Saeshin Precision Co., Ltd.

Saeshin Precision Co., Ltd.: FDA-registered device maker in Daegu, South Korea, 17 510(k) clearances

Name: Saeshin Precision Co., Ltd. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Saeshin Precision Co., Ltd. is registered with the FDA (registration 3007958831) in Daegu, South Korea. It lists 15 device types. The FDA files 17 510(k) clearances under its listings, the newest dated January 30, 2026. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3007958831
Address: 52, Secheon-ro 1-gil, Dasa-eup, Dalseong-gun, Daegu, South Korea, 711-814
Owner or operator: Saeshin Precision Co., Ltd. (10030579)
Roles: Manufacturer
First device listed: October 20, 2009
Registered through: 2026
Brand names listed: ACL(B)-61I, ACL(B)-62I, ACL(B)-63I, ACL(B)-65I, ACL(B)-04C, AF30R065KT, AHP-85-SS, ATD10YA, ATD10YH, ATD10YJ, ATK10YN, ATK11YN and more

Devices it lists

Device	Product code	Class	Role	Source
Blade, Saw, Surgical, Cardiovascular	DWH	1	Manufacturer	accessdata.fda.gov
Controller, Foot, Handpiece And Cord	EBW	1	Manufacturer	accessdata.fda.gov
Drill, Bone, Powered	DZI	2	Manufacturer	accessdata.fda.gov
Handle, Instrument, Dental	EJB	1	Manufacturer	accessdata.fda.gov
Handpiece, Air-Powered, Dental	EFB	1	Manufacturer	accessdata.fda.gov
Handpiece, Belt And/Or Gear Driven, Dental	EFA	1	Manufacturer	accessdata.fda.gov
Handpiece, Contra- And Right-Angle Attachment, Dental	EGS	1	Manufacturer	accessdata.fda.gov
Handpiece, Direct Drive, Ac-Powered	EKX	1	Manufacturer	accessdata.fda.gov
Handpiece, Water-Powered	EKY	1	Manufacturer	accessdata.fda.gov
Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment	HWE	1	Manufacturer	accessdata.fda.gov
Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment	KIJ	1	Manufacturer	accessdata.fda.gov
Motor, Drill, Electric	HBC	2	Manufacturer	accessdata.fda.gov
Motor, Surgical Instrument, Ac-Powered	GEY	1	Manufacturer	accessdata.fda.gov
Saw, Powered, And Accessories	HAB	1	Manufacturer	accessdata.fda.gov
Unit, Oral Irrigation	EFS	1	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
January 30, 2026	K251407	Motor Handpiece and Control Unit (SDI10)	EBW	Substantially Equivalent	Saeshin Precision Co., Ltd.	accessdata.fda.gov
September 20, 2024	K233153	Traus SSG10 Surgical System	HBC	Substantially Equivalent	Saeshin Precision Co., Ltd.	accessdata.fda.gov
September 16, 2024	K232938	Traus SSG30 Surgical System	HBC	Substantially Equivalent	Saeshin Precision Co., Ltd.	accessdata.fda.gov
February 22, 2023	K221741	TRAUS Air Dental Handpiece	EFB	Substantially Equivalent	Saeshin Precision Co., Ltd.	accessdata.fda.gov
February 11, 2021	K201292	TRAUS SIP20	EBW	Substantially Equivalent	Saeshin Precision Co., Ltd.	accessdata.fda.gov
July 13, 2020	K192561	TRAUS SUS20	DZI	Substantially Equivalent	Saeshin Precision Co., Ltd.	accessdata.fda.gov
November 26, 2019	K182892	TRAUS Dental Handpieces	EGS	Substantially Equivalent	Saeshin Precision Co., Ltd.	accessdata.fda.gov
January 31, 2019	K181129	STRONG Dental Handpieces	EGS	Substantially Equivalent	Saeshin Precision Co., Ltd.	accessdata.fda.gov
January 5, 2018	K171436	STRONG Dental Handpieces	EGS	Substantially Equivalent	Saeshin Precision Co., Ltd.	accessdata.fda.gov
September 1, 2015	K151171	TRAUS SUS10	DZI	Substantially Equivalent	Saeshin Precision Co., Ltd.	accessdata.fda.gov
July 31, 2015	K143418	STRONG Dental Handpieces	EGS	Substantially Equivalent	Saeshin Precision Co., Ltd.	accessdata.fda.gov
June 29, 2015	K143411	TRAUS ENDO	EKX	Substantially Equivalent	Saeshin Precision Co., Ltd.	accessdata.fda.gov
December 18, 2012	K123695	TRAUS SIP10	EKY	Substantially Equivalent	Saeshin Precision Co., Ltd.	accessdata.fda.gov
August 19, 2011	K111616	E-CUBE	EKX	Substantially Equivalent	Saeshin Precision Co., Ltd.	accessdata.fda.gov
February 4, 2010	K100192	STRONG DENTAL HANDPIECES	EGS	Substantially Equivalent	Saeshin Precision Co., Ltd.	accessdata.fda.gov
September 21, 2009	K092758	X-CUBE	EBW	Substantially Equivalent	Saeshin Precision Co., Ltd.	accessdata.fda.gov
September 3, 2009	K092412	STRONG IMPLANT HANDPIECES	EFA	Substantially Equivalent	Saeshin Precision Co., Ltd.	accessdata.fda.gov

Compare with other makers

Updated January 30, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.