Cleared Traditional

K070401 - ENDO-CHX (FDA 510(k) Clearance)

K070401 · Essential Dental Systems, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2007
Decision
149d
Days
-
Risk

K070401 is an FDA 510(k) clearance for the ENDO-CHX. Classified as Cleanser, Root Canal (product code KJJ).

Submitted by Essential Dental Systems, Inc. (Great Neck, US). The FDA issued a Cleared decision on July 11, 2007 after a review of 149 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 Essential Dental Systems, Inc. devices

Submission Details

510(k) Number K070401 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 12, 2007
Decision Date July 11, 2007
Days to Decision 149 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
22d slower than avg
Panel avg: 127d · This submission: 149d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KJJ Cleanser, Root Canal
Device Class -