Cleared Traditional

NEOSONO 2000 (K955088) - FDA 510(k) Clearance

K955088 · American Medical & Dental Corp. · Dental device
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Jul 1996
Decision
246d
Days
-
Risk

K955088 is an FDA 510(k) clearance for the NEOSONO 2000. Classified as Locator, Root Apex (product code LQY).

Submitted by American Medical & Dental Corp. (Cherry Hill, US). The FDA issued a Cleared decision on July 10, 1996 after a review of 246 days - an extended review 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: 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.

View all American Medical & Dental Corp. devices

Submission Details

510(k) Number K955088 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 07, 1995
Decision Date July 10, 1996
Days to Decision 246 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
119d slower than avg
Panel avg: 127d · This submission: 246d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LQY Locator, Root Apex
Device Class -