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510(k) K103123

APEX POINTER+; MEASRUING CABLE, HOOK, LIP CLIP, TOUCH PROBE (ACCESSORIES) by Micro-Mega Societe Anonyme — Product Code LQY

K103123 is an FDA 510(k) premarket notification submitted by Micro-Mega Societe Anonyme for the device "APEX POINTER+; MEASRUING CABLE, HOOK, LIP CLIP, TOUCH PROBE (ACCESSORIES)". The FDA issued a decision of Substantially Equivalent on March 10, 2011. The device falls under product code LQY (Locator, Root Apex), a Class U device. Micro-Mega Societe Anonyme has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 10, 2011
Date Received
October 21, 2010
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 Micro-Mega Societe Anonyme

  • K123276 — MM-SEAL (March 10, 2014)
  • K081268 — SONIC AIR MM1500 + (MID), MODEL 50400014 (August 10, 2009)
  • K042171 — AX'S ENDO 04, 06, 08, 2.5, 40 , MODELS 50100206, 50100217, 50100218, 50100230, 5 (November 10, 2004)
  • K971350 — SERIES XE, SERIES SE, SERIES TE (June 4, 1997)
  • K961275 — SIRIUS 10, 10L, 40, 40L (January 17, 1997)
  • K961235 — SIRIUS 180, 180L, 230, 230L (January 8, 1997)
  • K961494 — SERIES XE 140XE,40XE,10XE/SERIES SE 140SE,40SE,10SE/SERIES 10TE (June 26, 1996)
  • K961076 — MM 324 (April 26, 1996)
  • K950555 — J SINGLE USE HEAD AND JD REUSABLE HANDLE (December 28, 1995)
  • K951272 — RELACS 7000 (May 12, 1995)

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