Cleared Traditional

AONGEN DENTAL COLLAGEN MATRIX (K112568) - FDA 510(k) Clearance

K112568 · Aeon Astron Europe B.V. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2012
Decision
177d
Days
-
Risk

K112568 is an FDA 510(k) clearance for the AONGEN DENTAL COLLAGEN MATRIX. Classified as Oral Wound Dressing (product code OLR).

Submitted by Aeon Astron Europe B.V. (Leiden, NL). The FDA issued a Cleared decision on March 1, 2012 after a review of 177 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel. 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 General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

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Submission Details

510(k) Number K112568 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 06, 2011
Decision Date March 01, 2012
Days to Decision 177 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
62d slower than avg
Panel avg: 115d · This submission: 177d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code OLR Oral Wound Dressing
Device Class -
Definition Intended As A Physical Barrier For Temporary Protection Of Oral Mucosal Tissue And To Provide Pain Relief. Unclassified Status Per Se To Mgq.