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FDA 510(k)

scaffolene CL100 Bioresorbable Collagen Matrix

K-Number: K192346 · 2020-02-28

ApplicantFreudenberg Technology Innovation SE & Co. KG
Decision Date2020-02-28
Product CodeKGN
DecisionSubstantially Equivalent

Device Summary

scaffolene CL100 Bioresorbable Collagen Matrix is a medical device manufactured by Freudenberg Technology Innovation SE & Co. KG. It received FDA 510(k) clearance on 2020-02-28 under approval number K192346. The device is classified under product code KGN. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the scaffolene CL100 Bioresorbable Collagen Matrix?

scaffolene CL100 Bioresorbable Collagen Matrix is a medical device that received FDA 510(k) clearance on 2020-02-28. It is manufactured by Freudenberg Technology Innovation SE & Co. KG. The 510(k) number is K192346.

When was scaffolene CL100 Bioresorbable Collagen Matrix approved by the FDA?

scaffolene CL100 Bioresorbable Collagen Matrix received FDA 510(k) clearance on 2020-02-28, under approval number K192346.

What company makes scaffolene CL100 Bioresorbable Collagen Matrix?

scaffolene CL100 Bioresorbable Collagen Matrix is manufactured by Freudenberg Technology Innovation SE & Co. KG.

What is the FDA product code for scaffolene CL100 Bioresorbable Collagen Matrix?

The FDA product code for scaffolene CL100 Bioresorbable 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 NCT07605286 Soft Tissue Augmentation Around Dental Implants COMPLETED 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

Related Devices (Code: KGN)

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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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