Cleared Special

K022020 - JUSTWO MODEL TME-601 ROOT APEX LOCATOR

K022020 · Toei Electric Co., Ltd. · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2002
Decision
12d
Days
-
Risk

K022020 is an FDA 510(k) clearance for the JUSTWO MODEL TME-601 ROOT APEX LOCATOR. Classified as Locator, Root Apex (product code LQY).

Submitted by Toei Electric Co., Ltd. (Deer Field, US). The FDA issued a Cleared decision on July 2, 2002 after a review of 12 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K022020

510(k) Number K022020 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 20, 2002
Decision Date July 02, 2002
Days to Decision 12 days
Submission Type Special
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
116d faster than avg
Panel avg: 128d · This submission: 12d
Pathway characteristics
Modification to existing cleared device.

LQY Device Classification - Class 0,

Product Code LQY Locator, Root Apex
Device Class -

Regulatory Peers - LQY Locator, Root Apex

All 45
Devices cleared under the same product code (LQY) and FDA review panel - the closest regulatory comparables to K022020.
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APEX LOCATOR BINGO-1020
K992233 · Dent Corp. Research & Development · Nov 1999
ROOT APEX LOCATOR
K972407 · Toei Electric Co., Ltd. · Sep 1997
K022020 · JUSTWO MODEL TME-601 ROOT APEX LOCATOR
Download PDF FDA Summary Toei Electric Co., Lt…