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510(k) K212178

Root Apex Locator by Foshan Coxo Medical Instrument Co., Ltd. — Product Code LQY

K212178 is an FDA 510(k) premarket notification submitted by Foshan Coxo Medical Instrument Co., Ltd. for the device "Root Apex Locator". The FDA issued a decision of Substantially Equivalent on July 20, 2022. The device falls under product code LQY (Locator, Root Apex), a Class U device. Foshan Coxo Medical Instrument Co., Ltd. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 20, 2022
Date Received
July 12, 2021
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 Foshan Coxo Medical Instrument Co., Ltd.

  • K243921 — LED Curing Lights (DB686 HALO) (April 11, 2025)
  • K220179 — High-Speed Air Turbine Handpieces/Straight Handpieces/Geared Angle Handpieces/Ai (September 22, 2023)
  • K220829 — Endo Motor (May 18, 2023)
  • K222096 — Endo Ultrasonic Activator (March 23, 2023)
  • K220826 — LED Curing Light (December 8, 2022)
  • K220831 — Dental Implantation Systems, Dental Electrical Motors (September 27, 2022)

Other clearances for product code LQY

  • K252224 — Apex Locator (FindPex) (April 8, 2026)
  • 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)
  • 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