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510(k) K100450

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

K100450 is an FDA 510(k) premarket notification submitted by S-Denti Co., Ltd. for the device "I-ROOT". The FDA issued a decision of Substantially Equivalent on November 18, 2010. The device falls under product code LQY (Locator, Root Apex), a Class U device. S-Denti Co., Ltd. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 18, 2010
Date Received
February 17, 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 S-Denti Co., Ltd.

  • K112508 — I-ROOT 100 (June 19, 2012)
  • K112153 — IROOT 100 MINI (April 26, 2012)
  • K083901 — NAVI ROOT (April 15, 2009)

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