Cleared Traditional

ROOT APEX LOCATOR (K972407) - FDA 510(k) Clearance

K972407 · Toei Electric Co., Ltd. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1997
Decision
77d
Days
-
Risk

K972407 is an FDA 510(k) clearance for the ROOT APEX LOCATOR. Classified as Locator, Root Apex (product code LQY).

Submitted by Toei Electric Co., Ltd. (Washington, US). The FDA issued a Cleared decision on September 11, 1997 after a review of 77 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Toei Electric Co., Ltd. devices

Submission Details

510(k) Number K972407 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 26, 1997
Decision Date September 11, 1997
Days to Decision 77 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
50d faster than avg
Panel avg: 127d · This submission: 77d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LQY Locator, Root Apex
Device Class -