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510(k) K111474

BINGO PRO by Forum Engineering Technologies (96) , Ltd. — Product Code LQY

K111474 is an FDA 510(k) premarket notification submitted by Forum Engineering Technologies (96) , Ltd. for the device "BINGO PRO". The FDA issued a decision of Substantially Equivalent on November 2, 2011. The device falls under product code LQY (Locator, Root Apex), a Class U device. Forum Engineering Technologies (96) , Ltd. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 2, 2011
Date Received
May 27, 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 Forum Engineering Technologies (96) , Ltd.

  • K232551 — EM-07 Cordless Endo Motor (July 9, 2024)

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