Cleared Traditional

K864500 - ANALYTIC TECHNOLOGY ENDO ANALYZER MODEL 8001
(FDA 510(k) Clearance)

Mar 1987
Decision
125d
Days
Risk

K864500 is an FDA 510(k) clearance for the ANALYTIC TECHNOLOGY ENDO ANALYZER MODEL 8001. This device is classified as a Locator, Root Apex.

Submitted by Analytic Technology (Redmond, US). The FDA issued a Cleared decision on March 19, 1987, 125 days after receiving the submission on November 14, 1986.

This device falls under the Dental FDA review panel.

Submission Details

510(k) Number K864500 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 14, 1986
Decision Date March 19, 1987
Days to Decision 125 days
Submission Type Traditional
Review Panel Dental (DE)
Summary

Device Classification

Product Code LQY — Locator, Root Apex
Device Class

Similar Devices — LQY Locator, Root Apex

All 44
Apex Locator
K242383 · Shenzhen Rogin Medical Co., Ltd. · Mar 2025
Electronic Apex Locator (Alpha Apex I)
K242765 · SHENZHEN SUPERLINE TECHNOLOGY CO., LTD. · Jan 2025
Apex Locator
K231990 · Cefla S.C. · Feb 2024
Apex Locator (AL-Pex), Apex Locator (AL-Pex+)
K232717 · Changzhou Haili Medical Co., Ltd. · Dec 2023
Root Apex Locator
K212178 · Foshan Coxo Medical Instrument Co., Ltd. · Jul 2022
EQ-PEX
K210789 · Meta Systems Co., Ltd. · Oct 2021