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FDA 510(k)

ologen Collagen Matrix

K-Number: K173223 · 2018-03-02

ApplicantAeon Astron Europe B.V.
Decision Date2018-03-02
Product CodeKGN
DecisionSubstantially Equivalent

Device Summary

ologen Collagen Matrix is a medical device manufactured by Aeon Astron Europe B.V.. It received FDA 510(k) clearance on 2018-03-02 under approval number K173223. The device is classified under product code KGN. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ologen Collagen Matrix?

ologen Collagen Matrix is a medical device that received FDA 510(k) clearance on 2018-03-02. It is manufactured by Aeon Astron Europe B.V.. The 510(k) number is K173223.

When was ologen Collagen Matrix approved by the FDA?

ologen Collagen Matrix received FDA 510(k) clearance on 2018-03-02, under approval number K173223.

What company makes ologen Collagen Matrix?

ologen Collagen Matrix is manufactured by Aeon Astron Europe B.V..

What is the FDA product code for ologen Collagen Matrix?

The FDA product code for ologen Collagen Matrix is KGN.

Related Clinical Trials

NCT07613775 Volume-Stable Collagen Matrix Versus Subepithelial Connective Tissue Graft for Multiple Gingival Recessions NOT_YET_RECRUITING NCT06335628 Volumetric Dimensional Changes After Surgical Pontic Site Development Procedures With Connective Tissue Graft or Collagen Matrix RECRUITING NCT05081284 Clinical Outcomes of Immediate Implants With or Without a Volume-stable Collagen Matrix ACTIVE_NOT_RECRUITING NCT07546279 The Use of Two Bone Substitutes in Adjunct to EMD for the Treatment of One- and Two-wall Intrabony Defects. RECRUITING NCT07219316 Regenerative Collagen Scaffold for Breast Volume Restoration After Breast Cancer Excision COMPLETED

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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