Cleared Traditional

DECIDENT (K896364) - FDA 510(k) Clearance

Class I Dental device.

K896364 · Nevin Laboratories, Inc. · Dental device
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Jul 1990
Decision
255d
Days
Class 1
Risk

K896364 is an FDA 510(k) clearance for the DECIDENT. Classified as Handpiece, Water-powered (product code EKY), Class I - General Controls.

Submitted by Nevin Laboratories, Inc. (Chicago, US). The FDA issued a Cleared decision on July 19, 1990 after a review of 255 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4200 - 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 Nevin Laboratories, Inc. devices

Submission Details

510(k) Number K896364 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 06, 1989
Decision Date July 19, 1990
Days to Decision 255 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
128d slower than avg
Panel avg: 127d · This submission: 255d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EKY Handpiece, Water-powered
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.4200
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.