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510(k) K112508

I-ROOT 100 by S-Denti Co., Ltd. — Product Code LQY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 19, 2012
Date Received
August 30, 2011
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 S-Denti Co., Ltd.

  • K112153 — IROOT 100 MINI (April 26, 2012)
  • K100450 — I-ROOT (November 18, 2010)
  • K083901 — NAVI ROOT (April 15, 2009)

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)