Cleared Traditional

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

K090925 · J. Morita USA, Inc. · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (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.

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
107d slower than avg
Panel avg: 128d · 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

All 45
Devices cleared under the same product code (LQY) and FDA review panel - the closest regulatory comparables to K090925.
I-ROOT
K100450 · S-Denti Co., Ltd. · Nov 2010
APEXNRG RIDER
K101177 · Medicnrg , Ltd. · Oct 2010
ROMIAPEX MODEL A-15
K101054 · Romidan, Ltd. · Sep 2010
NAVI ROOT
K083901 · S-Denti Co., Ltd. · Apr 2009
APX21
K073185 · Techdent Technologies, Ltd. · Mar 2008
APEX DAL ELECTRONIC APEX LOCATOR
K080113 · Medicnrg , Ltd. · Feb 2008
K090925 · MULTIPLE (APEX LOCATOR), MODEL RCM-7
Download PDF FDA Summary J. Morita USA, Inc.