Cleared Traditional

K090925 - MULTIPLE (APEX LOCATOR), MODEL RCM-7

K090925 · J. Morita USA, Inc. · Dental device
Download Printable Device Report (PDF)
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

FDA 510(k) Submission Details - K090925

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
108d slower than avg
Panel avg: 127d · This submission: 235d
Pathway characteristics
Predicate-based equivalence.

LQY Device Classification - Class 0,

Product Code LQY Locator, Root Apex
Device Class -

Regulatory Peers - LQY Locator, Root Apex

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