Cleared Traditional

K140144 - BENDA WEDGE

K140144 is an FDA 510(k) clearance for BENDA WEDGE, manufactured by Centrix, Inc.. The device is a Class 1 Dental device with product code EJB cleared through the Traditional 510(k) pathway after a 167-day FDA review.

K140144 · Centrix, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2014
Decision
167d
Days
Class 1
Risk

K140144 is an FDA 510(k) clearance for the BENDA WEDGE. Classified as Handle, Instrument, Dental (product code EJB), Class I - General Controls.

Submitted by Centrix, Inc. (Shelton, US). The FDA issued a Cleared decision on July 8, 2014 after a review of 167 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4565 - the FDA dental device regulatory framework. 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 Centrix, Inc. devices

FDA 510(k) Submission Details - K140144

510(k) Number K140144 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 22, 2014
Decision Date July 08, 2014
Days to Decision 167 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
40d slower than avg
Panel avg: 127d · This submission: 167d
Pathway characteristics
Predicate-based equivalence.

EJB Device Classification - Class 1, General Controls

Product Code EJB Handle, Instrument, Dental
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.4565
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.