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Saeshin Precision Co., Ltd.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
18
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K251407Motor Handpiece and Control Unit (SDI10)January 30, 2026
K233153Traus SSG10 Surgical SystemSeptember 20, 2024
K232938Traus SSG30 Surgical SystemSeptember 16, 2024
K221741TRAUS Air Dental HandpieceFebruary 22, 2023
K212043TRAUS ENDOJune 24, 2022
K201292TRAUS SIP20February 11, 2021
K192561TRAUS SUS20July 13, 2020
K182892TRAUS Dental HandpiecesNovember 26, 2019
K181129STRONG Dental HandpiecesJanuary 31, 2019
K171436STRONG Dental HandpiecesJanuary 5, 2018
K151171TRAUS SUS10September 1, 2015
K143418STRONG Dental HandpiecesJuly 31, 2015
K143411TRAUS ENDOJune 29, 2015
K123695TRAUS SIP10December 18, 2012
K111616E-CUBEAugust 19, 2011
K100192STRONG DENTAL HANDPIECESFebruary 4, 2010
K092758X-CUBESeptember 21, 2009
K092412STRONG IMPLANT HANDPIECESSeptember 3, 2009