Cleared Special

IDENTIUM HEAVY, IDENTIUM MEDIUM, IDENTIUM SCAN HEAVY, IDENTIUM SCAN MEDIUM, IDENTIUM SCAN LIGHT (K113279) - FDA 510(k) Clearance

Class II Dental device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K113279 · Kettenbach GmbH & Co. KG · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2011
Decision
7d
Days
Class 2
Risk

K113279 is an FDA 510(k) clearance for the IDENTIUM HEAVY, IDENTIUM MEDIUM, IDENTIUM SCAN HEAVY, IDENTIUM SCAN MEDIUM, I.... Classified as Material, Impression (product code ELW), Class II - Special Controls.

Submitted by Kettenbach GmbH & Co. KG (Eschenburg, DE). The FDA issued a Cleared decision on November 14, 2011 after a review of 7 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3660 - 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. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Kettenbach GmbH & Co. KG devices

Submission Details

510(k) Number K113279 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 07, 2011
Decision Date November 14, 2011
Days to Decision 7 days
Submission Type Special
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
120d faster than avg
Panel avg: 127d · This submission: 7d
Pathway characteristics
Modification to existing cleared device. Third-party reviewed.

Device Classification

Product Code ELW Material, Impression
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3660
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.

Regulatory Peers - ELW Material, Impression

All 85
Devices cleared under the same product code (ELW) and FDA review panel - the closest regulatory comparables to K113279.
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