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510(k) K212043

TRAUS ENDO by Saeshin Precision Co., Ltd. — Product Code EKX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 24, 2022
Date Received
June 30, 2021
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

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

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Other clearances for product code EKX

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  • K242514 — Endo Motor (E-LITE MAX, E-LITE PRO, E-LITE INO) (April 24, 2025)
  • K241065 — ChecQ (AC100) (March 21, 2025)
  • K243911 — HPR Cordless Hygiene Handpiece (December 20, 2024)
  • K222688 — The Trust (August 9, 2024)
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  • K232551 — EM-07 Cordless Endo Motor (July 9, 2024)
  • K232810 — Dental Handpiece, Wireless Endodontic Handpiece, endoit (November 9, 2023)