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510(k) K252224

Apex Locator (FindPex) by Changzhou Sifary Medical Technology Co., Ltd. — Product Code LQY

K252224 is an FDA 510(k) premarket notification submitted by Changzhou Sifary Medical Technology Co., Ltd. for the device "Apex Locator (FindPex)". The FDA issued a decision of Substantially Equivalent on April 8, 2026. The device falls under product code LQY (Locator, Root Apex), a Class U device. Changzhou Sifary Medical Technology Co., Ltd. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 8, 2026
Date Received
July 16, 2025
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 Sifary Medical Technology Co., Ltd.

  • K232068 — HyperLight Portable X-ray Unit (September 1, 2023)
  • K221152 — CuringPen Dental Curing Light (November 23, 2022)
  • K201993 — E-connect S Endo Motor with built-in Apex Locator (January 29, 2021)

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)
  • K203836 — BOMEDENT Apex locator, WISMY Apex locator (March 30, 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)

FDA data resources