Cleared Traditional

K090925 - MULTIPLE (APEX LOCATOR), MODEL RCM-7 (FDA 510(k) Clearance)

K090925 · J. Morita USA, Inc. · Dental device
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Optimized for regulatory review, auditing and printing
Nov 2009
Decision
235d
Days
-
Risk

K090925 is an FDA 510(k) clearance for the MULTIPLE (APEX LOCATOR), MODEL RCM-7. Classified as Locator, Root Apex (product code LQY).

Submitted by J. Morita USA, Inc. (Washington, US). The FDA issued a Cleared decision on November 23, 2009 after a review of 235 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 J. Morita USA, Inc. devices

Submission Details

510(k) Number K090925 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 02, 2009
Decision Date November 23, 2009
Days to Decision 235 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
108d slower than avg
Panel avg: 127d · This submission: 235d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LQY Locator, Root Apex
Device Class -