Cleared Traditional

NEOSONO (K962853) - FDA 510(k) Clearance

K962853 · L.S. Scientific · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1996
Decision
52d
Days
-
Risk

K962853 is an FDA 510(k) clearance for the NEOSONO. Classified as Locator, Root Apex (product code LQY).

Submitted by L.S. Scientific (Riverside, US). The FDA issued a Cleared decision on September 12, 1996 after a review of 52 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 L.S. Scientific devices

Submission Details

510(k) Number K962853 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 22, 1996
Decision Date September 12, 1996
Days to Decision 52 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
75d faster than avg
Panel avg: 127d · This submission: 52d
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 K962853.
Apex Locator (FindPex)
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Apex Locator
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Electronic Apex Locator (Alpha Apex I)
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