Cleared Traditional

K151987 - DCI Edge Dental Chair with Operative Unit (FDA 510(k) Clearance)

Class I Dental device.

K151987 · Dci · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2016
Decision
320d
Days
Class 1
Risk

K151987 is an FDA 510(k) clearance for the DCI Edge Dental Chair with Operative Unit. Classified as Chair, Dental, With Operative Unit (product code KLC), Class I - General Controls.

Submitted by Dci (Newberg, US). The FDA issued a Cleared decision on June 1, 2016 after a review of 320 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.6250 - 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. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

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Submission Details

510(k) Number K151987 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 17, 2015
Decision Date June 01, 2016
Days to Decision 320 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
193d slower than avg
Panel avg: 127d · This submission: 320d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KLC Chair, Dental, With Operative Unit
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.6250
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.