Cleared Special

K120239 - ELEVANCE

K120239 is an FDA 510(k) clearance for ELEVANCE, manufactured by Midmark. The device is a Class 1 Dental device with product code EIA cleared through the Special 510(k) pathway after a 211-day FDA review.

K120239 · Midmark · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (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.

FDA 510(k) Submission Details - K120239

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
83d slower than avg
Panel avg: 128d · This submission: 211d
Pathway characteristics
Modification to existing cleared device.

EIA Device Classification - Class 1, General Controls

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 261
Devices cleared under the same product code (EIA) and FDA review panel - the closest regulatory comparables to K120239.
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TRITON SELF CONTAINED DENTAL SYSTEM, TRITON SELF CONTAINED DENTAL SYSTEM, WITH CASE
K110481 · Asi Medical, Inc. · Apr 2012
DYNAMIC DU SERIES PORTABLE DENTAL UNIT
K111907 · Shanghai Dynamic Industry Co., Ltd. · Dec 2011
CS 1200
K112321 · Carestream Health, Inc. · Nov 2011
K120239 · ELEVANCE
Download PDF FDA Summary Midmark