Home / 510(k) Clearances / K080113

510(k) K080113

APEX DAL ELECTRONIC APEX LOCATOR by Medicnrg , Ltd. — Product Code LQY

K080113 is an FDA 510(k) premarket notification submitted by Medicnrg , Ltd. for the device "APEX DAL ELECTRONIC APEX LOCATOR". The FDA issued a decision of Substantially Equivalent on February 15, 2008. The device falls under product code LQY (Locator, Root Apex), a Class U device. Medicnrg , Ltd. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 15, 2008
Date Received
January 16, 2008
Clearance Type
Special
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 Medicnrg , Ltd.

  • K101177 — APEXNRG RIDER (October 8, 2010)
  • K071133 — APEXNRG-BLUE ELECTRONIC APEX LOCATOR (September 21, 2007)
  • K063843 — APEXNRG XFR (January 3, 2007)
  • K032743 — APEX NRG (March 15, 2004)

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)
  • 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)

FDA data resources