Cleared Traditional

K854467 - S.T.P.B SOFT TISSUES PROTECTIVES BLADES

K854467 is an FDA 510(k) clearance for S.T.P.B SOFT TISSUES PROTECTIVES BLADES, manufactured by Nortex USA, Inc.. The device is a Class 1 Dental device with product code EEJ cleared through the Traditional 510(k) pathway after a 126-day FDA review.

K854467 · Nortex USA, Inc. · Dental device
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Mar 1986
Decision
126d
Days
Class 1
Risk

K854467 is an FDA 510(k) clearance for the S.T.P.B SOFT TISSUES PROTECTIVES BLADES. Classified as Guard, Disk (product code EEJ), Class I - General Controls.

Submitted by Nortex USA, Inc. (Washington, US). The FDA issued a Cleared decision on March 12, 1986 after a review of 126 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.6010 - 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 Nortex USA, Inc. devices

FDA 510(k) Submission Details - K854467

510(k) Number K854467 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 06, 1985
Decision Date March 12, 1986
Days to Decision 126 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
2d faster than avg
Panel avg: 128d · This submission: 126d
Pathway characteristics
Predicate-based equivalence.

EEJ Device Classification - Class 1, General Controls

Product Code EEJ Guard, Disk
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.6010
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.