Cleared Traditional

K926368 - APPLICATOR NOZZLE (FDA 510(k) Clearance)

Class I Dental device.

K926368 · Centrix, Inc. · Dental device
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Sep 1993
Decision
267d
Days
Class 1
Risk

K926368 is an FDA 510(k) clearance for the APPLICATOR NOZZLE. Classified as Burnisher, Operative (product code EKJ), Class I - General Controls.

Submitted by Centrix, Inc. (Shelton, US). The FDA issued a Cleared decision on September 15, 1993 after a review of 267 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

Submission Details

510(k) Number K926368 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 22, 1992
Decision Date September 15, 1993
Days to Decision 267 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
140d slower than avg
Panel avg: 127d · This submission: 267d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EKJ Burnisher, Operative
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.