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510(k) K233153

Traus SSG10 Surgical System by Saeshin Precision Co., Ltd. — Product Code HBC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 20, 2024
Date Received
September 27, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Motor, Drill, Electric
Device Class
Class II
Regulation Number
882.4360
Review Panel
NE
Submission Type

Other clearances by Saeshin Precision Co., Ltd.

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  • 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)
  • K151171 — TRAUS SUS10 (September 1, 2015)

Other clearances for product code HBC

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  • K213697 — ORiGO System (October 31, 2022)
  • K220485 — Wireless Hand Control, EG1A (WIRELESS-HC), Receiver for Wireless Hand Control, E (May 19, 2022)
  • K193630 — hekaDrill (April 9, 2021)
  • K183515 — MR8 Drill System, Midas Rex MR8 ClearView Tools (May 12, 2019)
  • K173066 — OSSEODUO Shaver and Drill System (June 22, 2018)
  • K170312 — IPC systems, Legend EHS handpieces and Legend Stylus Touch handpiece, Microsaw h (May 15, 2017)
  • K163565 — MR8 Drill System (March 28, 2017)
  • K152960 — ELAN 4 Motor System (July 22, 2016)
  • K133604 — ANSPACH EG1 HIGH SPEED SYSTEM, G1 ATTACHMENTS (January 10, 2014)