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510(k) K191806

Propex IQ Apex Locator by Dentsply Sirona — Product Code LQY

K191806 is an FDA 510(k) premarket notification submitted by Dentsply Sirona for the device "Propex IQ Apex Locator". The FDA issued a decision of Substantially Equivalent on October 3, 2019. The device falls under product code LQY (Locator, Root Apex), a Class U device. Dentsply Sirona has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 3, 2019
Date Received
July 5, 2019
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 Dentsply Sirona

  • K261935 — Surgical and Prosthetic Trays (September 4, 2026)
  • K262127 — DS Core CBCT Anatomy (August 21, 2026)
  • K260785 — DS Core CBCT Anatomy (April 23, 2026)
  • K260722 — SureSmile Aligner (ASSY500020) (April 15, 2026)
  • K253565 — SureSmile Software (March 4, 2026)
  • K251614 — Stainless Steel Surgical Kits (February 6, 2026)
  • K253959 — Primevision 3D (February 5, 2026)
  • K253009 — DS Core Detect (January 7, 2026)
  • K252343 — Atlantis® Abutments in Titanium (December 9, 2025)
  • K252248 — CEREC Tessera Abutment System (November 26, 2025)

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)
  • K181087 — Apex Locator, DPEX III (December 18, 2018)
  • K171867 — Dr’s Finder NEO (March 30, 2018)

FDA data resources