Cleared Traditional

K962853 - NEOSONO

K962853 · L.S. Scientific · Dental device

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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.

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FDA 510(k) Submission Details - K962853

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
Combination Product	No
PCCP Authorized	No

Regulatory Context

Review time vs. panel average

75d faster than avg

Panel avg: 127d · This submission: 52d

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 24

Devices cleared under the same product code (LQY) and FDA review panel - the closest regulatory comparables to K962853.

APEX LOCATOR BINGO-1020

K992233 · Dent Corp. Research & Development · Nov 1999

ROOT APEX LOCATOR

K972407 · Toei Electric Co., Ltd. · Sep 1997

APEX FINDER MODELS 7005

K962803 · Sybron Dental Specialties, Inc. · Oct 1996

NEOSONO 2000

K955088 · American Medical & Dental Corp. · Jul 1996

ROOT CANAL LENGTH MEASURING DEVICE

K953867 · J. Morita USA, Inc. · Dec 1995

FORAMATRON IV

K950857 · Parkell, Inc. · Apr 1995

FDA 510(k) Resources - Dental

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

Manufacturer of K962853

L.S. Scientific

Riverside, NJ · US

LEONARD SALESKY

Regulatory profile

2 submissions 1 cleared

50% clearance rate · Active in Dental

About This 510(k) Record

This record restructures FDA 510(k) public data into device-level regulatory intelligence - enabling comparison across product codes, clearance pathways, review times and manufacturer patterns.

Classification enrichment, manufacturer tracking and cross-device links are added to support regulatory research and predicate analysis workflows.

Sourced from FDA 510(k) public files . FDA decision: September 12, 1996. Record added to 510k Database: March 2026. Enriched with classification and manufacturer data: September 2026.

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