Home / 510(k) Clearances / K123695

510(k) K123695

TRAUS SIP10 by Saeshin Precision Co., Ltd. — Product Code EKY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 18, 2012
Date Received
December 3, 2012
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Handpiece, Water-Powered
Device Class
Class I
Regulation Number
872.4200
Review Panel
DE
Submission Type

Other clearances by Saeshin Precision Co., Ltd.

  • K251407 — Motor Handpiece and Control Unit (SDI10) (January 30, 2026)
  • K233153 — Traus SSG10 Surgical System (September 20, 2024)
  • K232938 — Traus SSG30 Surgical System (September 16, 2024)
  • K221741 — TRAUS Air Dental Handpiece (February 22, 2023)
  • K212043 — TRAUS ENDO (June 24, 2022)
  • K201292 — TRAUS SIP20 (February 11, 2021)
  • K192561 — TRAUS SUS20 (July 13, 2020)
  • K182892 — TRAUS Dental Handpieces (November 26, 2019)
  • K181129 — STRONG Dental Handpieces (January 31, 2019)
  • K171436 — STRONG Dental Handpieces (January 5, 2018)

Other clearances for product code EKY

  • K896364 — DECIDENT (July 19, 1990)