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510(k) K192561

TRAUS SUS20 by Saeshin Precision Co., Ltd. — Product Code DZI

K192561 is an FDA 510(k) premarket notification submitted by Saeshin Precision Co., Ltd. for the device "TRAUS SUS20". The FDA issued a decision of Substantially Equivalent on July 13, 2020. The device falls under product code DZI (Drill, Bone, Powered), a Class II device regulated under 21 CFR 872.4120. Saeshin Precision Co., Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 13, 2020
Date Received
September 17, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Drill, Bone, Powered
Device Class
Class II
Regulation Number
872.4120
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)
  • 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 DZI

  • K253776 — Implantmed Plus II & Piezomed Plus II Module (June 18, 2026)
  • K254163 — VarioSurg 4 (December 23, 2025)
  • K242432 — MT-Bone (August 19, 2024)
  • K240340 — Surgical Drive System (Model: ES70, ES90, E8) (July 18, 2024)
  • K231087 — Guided Surgery Kit (August 16, 2023)
  • K200265 — Surgical Drills (June 30, 2020)
  • K192033 — Contour P-Insert 90, Contour P-Insert 45, Contour P-Insert Tri Tip, Contour P-In (June 9, 2020)
  • K172137 — PIEZOTOME CUBE (May 3, 2018)
  • K171326 — Piezosurgery White (April 13, 2018)
  • K171958 — PIEZOSURGERY TOUCH, PIEZOSURGERY WHITE (January 12, 2018)

FDA data resources