Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3007958831

FEI Number

3007958831

Entity Name

SAESHIN PRECISION CO., LTD.

City/State/Country

Daegu, KR

Establishment Address

52, Secheon-ro 1-gil, Dasa-eup, Dalseong-gun, Daegu 711-814, KR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Saeshin Precision Co., Ltd. (Owner Number: 10030579)

Owner / Operator Contact Address

52, Secheon-ro 1-gil, Dasa-eup,, Dalseong-gun, Daegu, KR-27 42921, KR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Strong Dental Handpieces MEARA; MEAHP TRAUS high-speed air turbine Handpieces SSG30 DB-003 DB-001 DB-005 ACL(B)-61I, ACL(B)-62I, ACL(B)-63I, ACL(B)-65I, ACL(B)-04C Maxima Elite i Maxima Elite iL AHP-85-SS BIODENT SIP10 TRAUS SIP 10 AHP-85-SS Traus SIP20 DENTIS DIP20 STRONG IMPLANT HANDPIECES SSG10 Traus SUS20 PIEZOART RF503NU8 WF20R065KT SD507A RD703NU CF22R075KT RF303NU8 TA114C CF20R65KT TA115C RF703NU8 RD303NU SB300A TA110B CF31R070KT CF30R100KT TRAUS SSG10 Blade System RD503NU WF29R065KT AF30R065KT TA113C X-CUBE OsseoFuse Harpoon 1 TRAUS CRB46LN TRAUS CRB46NN TRAUS SSG40 ATR10YJ ATS10YS TRAUS SSG20 ATS10YR ATK11YN ATK10YN ATK12YN ATD10YA ATD10YH TD-AUTO ATR10YA ATD10YJ ATR10YH E-cube EM type Motor set B350D motor set FUE straight handpiece Strong AT-II B170 motor set

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EGS	Handpiece, Contra- And Right-Angle Attachment, Dental	Dental	Class 1	872.4200	2010-02-26
EFB	Handpiece, Air-Powered, Dental	Dental	Class 1	872.4200	2023-03-08
HBC	Motor, Drill, Electric	Neurology	Class 2	882.4360	2024-11-19
EFS	Unit, Oral Irrigation	Dental	Class 1	872.6510	2017-02-23
EBW	Controller, Foot, Handpiece And Cord	Dental	Class 1	872.4200	2015-09-20
DZI	Drill, Bone, Powered	Dental	Class 2	872.4120	2015-09-20
EGS	Handpiece, Contra- And Right-Angle Attachment, Dental	Dental	Class 1	872.4200	2015-09-20
EGS	Handpiece, Contra- And Right-Angle Attachment, Dental	Dental	Class 1	872.4200	2018-01-07
EKX	Handpiece, Direct Drive, Ac-Powered	Dental	Class 1	872.4200	2015-06-30
EKY	Handpiece, Water-Powered	Dental	Class 1	872.4200	2013-01-21
EGS	Handpiece, Contra- And Right-Angle Attachment, Dental	Dental	Class 1	872.4200	2021-02-14
EBW	Controller, Foot, Handpiece And Cord	Dental	Class 1	872.4200	2021-02-14
EJB	Handle, Instrument, Dental	Dental	Class 1	872.4565	2018-03-13
EFA	Handpiece, Belt And/Or Gear Driven, Dental	Dental	Class 1	872.4200	2009-10-20
HBC	Motor, Drill, Electric	Neurology	Class 2	882.4360	2024-11-19
DZI	Drill, Bone, Powered	Dental	Class 2	872.4120	2020-07-14
DWH	Blade, Saw, Surgical, Cardiovascular	General, Plastic Surgery	Class 1	878.4820	2019-07-25
EBW	Controller, Foot, Handpiece And Cord	Dental	Class 1	872.4200	2009-10-20
EGS	Handpiece, Contra- And Right-Angle Attachment, Dental	Dental	Class 1	872.4200	2015-08-03
EGS	Handpiece, Contra- And Right-Angle Attachment, Dental	Dental	Class 1	872.4200	2019-12-03
KIJ	Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment	General, Plastic Surgery	Class 1	878.4820	2023-03-27
GEY	Motor, Surgical Instrument, Ac-Powered	General, Plastic Surgery	Class 1	878.4820	2024-06-24

Official Correspondent

Jung Ho LEE

US Agent Details

Youngsun Lee Business: Saeshin America, Inc Email: sales@saeshin.com Phone: (949) 8256925

Related Public Records

Same Entity

Saeshin Precision 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
K212910	Shenzhen Carejoy Technology Co., Ltd.	Dental High-speed Turbine Handpiece, Dental Low-speed Turbine Handpiece	2022-11-17
K844318	Pro Pulse, Inc.	ORAL IRRIGATION TIP	1984-11-23
K040153	Indigenous Peoples Technology and Education Center	I-TEC PORTABLE DENTAL OPERATORY	2004-05-21
K241065	Dentis Co., Ltd.	ChecQ (AC100)	2025-03-21
K933337	R & D Batteries, Inc.	R AND D BATTERY REPLACEMENT	1994-04-05

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9710363	BONART CO. LTD.	KEELUNG, TW
1223843	BICON, LLC	Boston, MA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3007958831. Last updated year: 2026. Please use registration number 3007958831 when referencing this establishment in official correspondence.