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510(k) K904742

OSADA ENDEX by Osada Electric Co., Ltd. — Product Code LQY

K904742 is an FDA 510(k) premarket notification submitted by Osada Electric Co., Ltd. for the device "OSADA ENDEX". The FDA issued a decision of Substantially Equivalent on December 17, 1990. The device falls under product code LQY (Locator, Root Apex), a Class U device. Osada Electric Co., Ltd. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 17, 1990
Date Received
October 18, 1990
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 Osada Electric Co., Ltd.

  • K935443 — ADD LINE DEVICES(PARTS) ELECTRIC HANDPIECE SYSTEMS (September 20, 1994)
  • K844250 — OSADA ENAC (January 23, 1985)

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