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510(k) K203836

BOMEDENT Apex locator, WISMY Apex locator by Changzhou Bomedent Medical Technology Co.,Ltd — Product Code LQY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 30, 2021
Date Received
December 30, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Locator, Root Apex
Device Class
Class U
Regulation Number
Review Panel
DE
Submission Type

Other clearances by Changzhou Bomedent Medical Technology Co.,Ltd

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Other clearances for product code LQY

  • K242383 — Apex Locator (March 7, 2025)
  • K242765 — Electronic Apex Locator (Alpha Apex I) (January 17, 2025)
  • K231990 — Apex Locator (February 13, 2024)
  • K232717 — Apex Locator (AL-Pex), Apex Locator (AL-Pex+) (December 22, 2023)
  • K212178 — Root Apex Locator (July 20, 2022)
  • K210789 — EQ-PEX (October 20, 2021)
  • K191806 — Propex IQ Apex Locator (October 3, 2019)
  • K181087 — Apex Locator, DPEX III (December 18, 2018)
  • K171867 — Dr’s Finder NEO (March 30, 2018)
  • K151274 — Dr's Finder (February 4, 2016)