Medical Device Manufacturer · KR , Seoul

Saeshin Precision Co., Ltd.

18 submissions · 18 cleared · Since 2009
18
Total
18
Cleared
0
Denied

Saeshin Precision Co., Ltd. — FDA 510(k) Submissions

Saeshin Precision Co., Ltd. has submitted 18 FDA 510(k) premarket notifications since 2009, of which 18 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Handpiece, Contra- And Right-angle Attachment, Dental, Controller, Foot, Handpiece And Cord, Handpiece, Direct Drive, Ac-powered, Drill, Bone, Powered, Motor, Drill, Electric . Use the specialty filter in the sidebar to narrow results.

18 devices
1–18 of 18
Motor Handpiece and Control Unit (SDI10)
K251407 · EBW Controller, Foot,... · Dental
Jan 2026 269d
Traus SSG10 Surgical System
K233153 · HBC Motor, Drill, Electric · Neurology
Sep 2024 359d
Traus SSG30 Surgical System
K232938 · HBC Motor, Drill, Electric · Neurology
Sep 2024 362d
TRAUS Air Dental Handpiece
K221741 · EFB Handpiece, Air-powered,... · Dental
Feb 2023 252d
TRAUS ENDO
K212043 · EKX Handpiece, Direct Drive,... · Dental
Jun 2022 359d
TRAUS SIP20
K201292 · EBW Controller, Foot,... · Dental
Feb 2021 273d
TRAUS SUS20
K192561 · DZI Drill, Bone, Powered · Dental
Jul 2020 300d
TRAUS Dental Handpieces
K182892 · EGS Handpiece, Contra- And... · Dental
Nov 2019 407d
STRONG Dental Handpieces
K181129 · EGS Handpiece, Contra- And... · Dental
Jan 2019 276d
STRONG Dental Handpieces
K171436 · EGS Handpiece, Contra- And... · Dental
Jan 2018 234d
TRAUS SUS10
K151171 · DZI Drill, Bone, Powered · Dental
Sep 2015 123d
STRONG Dental Handpieces
K143418 · EGS Handpiece, Contra- And... · Dental
Jul 2015 245d
TRAUS ENDO
K143411 · EKX Handpiece, Direct Drive,... · Dental
Jun 2015 213d
TRAUS SIP10
K123695 · EKY Handpiece, Water-powered · Dental
Dec 2012 15d
E-CUBE
K111616 · EKX Handpiece, Direct Drive,... · Dental
Aug 2011 70d
STRONG DENTAL HANDPIECES
K100192 · EGS Handpiece, Contra- And... · Dental
Feb 2010 13d
X-CUBE
K092758 · EBW Controller, Foot,... · Dental
Sep 2009 12d
STRONG IMPLANT HANDPIECES
K092412 · EFA Handpiece, Belt And/or... · Dental
Sep 2009 28d
Filters