Cleared Traditional

NSK PRECISION APEX LOCATOR (PAL) (K053235) - FDA 510(k) Clearance

K053235 · Medicsense USA · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2006
Decision
67d
Days
-
Risk

K053235 is an FDA 510(k) clearance for the NSK PRECISION APEX LOCATOR (PAL). Classified as Locator, Root Apex (product code LQY).

Submitted by Medicsense USA (Somerset, US). The FDA issued a Cleared decision on January 24, 2006 after a review of 67 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Medicsense USA devices

Submission Details

510(k) Number K053235 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 18, 2005
Decision Date January 24, 2006
Days to Decision 67 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
60d faster than avg
Panel avg: 127d · This submission: 67d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 K053235.
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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