Cleared Traditional

K896364 - DECIDENT

K896364 is an FDA 510(k) clearance for DECIDENT, manufactured by Nevin Laboratories, Inc.. The device is a Class 1 Dental device with product code EKY cleared through the Traditional 510(k) pathway after a 255-day FDA review.

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

FDA 510(k) Submission Details - K896364

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.

EKY Device Classification - Class 1, General Controls

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.