Cleared Traditional

K182017 - Compex HD (FDA 510(k) Clearance)

Class I Dental device.

K182017 · Addent, Inc. · Dental device
Apr 2019
Decision
276d
Days
Class 1
Risk

K182017 is an FDA 510(k) clearance for the Compex HD. Classified as Composite Resin Warmer (product code QGO), Class I - General Controls.

Submitted by Addent, Inc. (Danbury, US). The FDA issued a Cleared decision on April 29, 2019 after a review of 276 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.6100 - 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.

Submission Details

510(k) Number K182017 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 27, 2018
Decision Date April 29, 2019
Days to Decision 276 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Regulatory Context
Review time vs. panel average
118d slower than avg
Panel avg: 158d · This submission: 276d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code QGO Composite Resin Warmer
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.6100
Definition Intended To Warm Composite Materials Prior To Use
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.