Cleared Special

ELEVANCE (K120239) - FDA 510(k) Clearance

Class I Dental device.

K120239 · Midmark · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2012
Decision
211d
Days
Class 1
Risk

K120239 is an FDA 510(k) clearance for the ELEVANCE. Classified as Unit, Operative Dental (product code EIA), Class I - General Controls.

Submitted by Midmark (Fullerton, US). The FDA issued a Cleared decision on August 24, 2012 after a review of 211 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.6640 - the FDA dental device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Midmark devices

Submission Details

510(k) Number K120239 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 26, 2012
Decision Date August 24, 2012
Days to Decision 211 days
Submission Type Special
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
84d slower than avg
Panel avg: 127d · This submission: 211d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code EIA Unit, Operative Dental
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.6640
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.

Regulatory Peers - EIA Unit, Operative Dental

All 25
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