Home / 510(k) Clearances / K864500

510(k) K864500

ANALYTIC TECHNOLOGY ENDO ANALYZER MODEL 8001 by Analytic Technology — Product Code LQY

K864500 is an FDA 510(k) premarket notification submitted by Analytic Technology for the device "ANALYTIC TECHNOLOGY ENDO ANALYZER MODEL 8001". The FDA issued a decision of Substantially Equivalent on March 19, 1987. The device falls under product code LQY (Locator, Root Apex), a Class U device. Analytic Technology has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 19, 1987
Date Received
November 14, 1986
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 Analytic Technology

  • K921604 — TOUCH N' HEAT, MODIFICATION (August 24, 1992)
  • K915243 — TOUCH 'N HEAT MODEL 5002, MODIFICATION (January 21, 1992)
  • K890735 — COATED APEX PROBE (April 19, 1989)
  • K832179 — HOT PROBE MODEL 6001 (October 4, 1983)
  • K823486 — TOUCH-N-HEAT MODEL 5001 (January 18, 1983)
  • K820598 — HOT & COLD PULP TESTER #4001 (March 19, 1982)
  • K801974 — ANALYTIC TECH. METAL POINT HEATER #3001 (November 12, 1980)
  • K790799 — PULPTESTER MODEL 2001 (May 31, 1979)

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