Cleared Traditional

K953867 - ROOT CANAL LENGTH MEASURING DEVICE (FDA 510(k) Clearance)

K953867 · J. Morita USA, Inc. · Dental device
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Dec 1995
Decision
106d
Days
-
Risk

K953867 is an FDA 510(k) clearance for the ROOT CANAL LENGTH MEASURING DEVICE. Classified as Locator, Root Apex (product code LQY).

Submitted by J. Morita USA, Inc. (Irvine, US). The FDA issued a Cleared decision on December 1, 1995 after a review of 106 days - within the typical 510(k) review window.

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 K953867 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 17, 1995
Decision Date December 01, 1995
Days to Decision 106 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
21d faster than avg
Panel avg: 127d · This submission: 106d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LQY Locator, Root Apex
Device Class -