Cleared Traditional

K073185 - APX21

K073185 · Techdent Technologies, Ltd. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2008
Decision
114d
Days
-
Risk

K073185 is an FDA 510(k) clearance for the APX21. Classified as Locator, Root Apex (product code LQY).

Submitted by Techdent Technologies, Ltd. (M.P. Misgav, IL). The FDA issued a Cleared decision on March 6, 2008 after a review of 114 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Techdent Technologies, Ltd. devices

FDA 510(k) Submission Details - K073185

510(k) Number K073185 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 13, 2007
Decision Date March 06, 2008
Days to Decision 114 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
13d faster than avg
Panel avg: 127d · This submission: 114d
Pathway characteristics
Predicate-based equivalence.

LQY Device Classification - Class 0,

Product Code LQY Locator, Root Apex
Device Class -

Regulatory Peers - LQY Locator, Root Apex

All 23
Devices cleared under the same product code (LQY) and FDA review panel - the closest regulatory comparables to K073185.
Dr’s Finder NEO
K171867 · Good Doctors Co., Ltd. · Mar 2018
RAYPEX 6
K131907 · Dentsply International, Inc. · Jan 2014
MULTIPLE (APEX LOCATOR), MODEL RCM-7
K090925 · J. Morita USA, Inc. · Nov 2009
ASEPTICO ENDOPEX V, MODEL AEU-40
K030895 · Aseptico, Inc. · Dec 2003
DENTA PORT
K022147 · J. Morita USA, Inc. · Dec 2002
FORAMATRON V, MODEL D680
K002195 · Parkell, Inc. · Aug 2000