Cleared Traditional

K182017 - Compex HD

K182017 is an FDA 510(k) clearance for Compex HD, manufactured by Addent, Inc.. The device is a Class 1 Dental device with product code QGO cleared through the Traditional 510(k) pathway after a 276-day FDA review.

K182017 · Addent, Inc. · Dental device
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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.

View all Addent, Inc. devices

FDA 510(k) Submission Details - K182017

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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
149d slower than avg
Panel avg: 127d · This submission: 276d
Pathway characteristics
Predicate-based equivalence.

QGO Device Classification - Class 1, General Controls

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.