Cleared Traditional

K053235 - NSK PRECISION APEX LOCATOR (PAL)

K053235 · Medicsense USA · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (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.

FDA 510(k) Submission Details - K053235

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
61d faster than avg
Panel avg: 128d · This submission: 67d
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
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DENTA PORT
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K053235 · NSK PRECISION APEX LOCATOR (PAL)
Download PDF FDA Summary Medicsense USA