Cleared Traditional

K073185 - APX21

K073185 · Techdent Technologies, Ltd. · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (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.

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
14d faster than avg
Panel avg: 128d · 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 45
Devices cleared under the same product code (LQY) and FDA review panel - the closest regulatory comparables to K073185.
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K071133 · Medicnrg , Ltd. · Sep 2007
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K063843 · Medicnrg , Ltd. · Jan 2007
K073185 · APX21
Download PDF FDA Summary Techdent Technologies…