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FDA 510(k)

Collagen Dental Wound Dressings

K-Number: K152600 · 2016-06-23

ApplicantCollagen Matrix, Inc.
Decision Date2016-06-23
Product CodeKGN
DecisionSubstantially Equivalent

Device Summary

Collagen Dental Wound Dressings is the device name listed in this FDA 510(k) record. The listed applicant is Collagen Matrix, Inc.. It received FDA 510(k) clearance on 2016-06-23 under 510(k) number K152600. The device is classified under product code KGN. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Collagen Dental Wound Dressings?

Collagen Dental Wound Dressings is a medical device that received FDA 510(k) clearance on 2016-06-23. The listed applicant is Collagen Matrix, Inc.. The 510(k) number is K152600.

When did Collagen Dental Wound Dressings receive FDA 510(k) clearance?

Collagen Dental Wound Dressings received FDA 510(k) clearance on 2016-06-23, under 510(k) number K152600.

Who is the listed applicant for Collagen Dental Wound Dressings?

The FDA 510(k) record lists Collagen Matrix, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Collagen Dental Wound Dressings?

The FDA product code for Collagen Dental Wound Dressings is KGN.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT05081284Clinical Outcomes of Immediate Implants With or Without a Volume-stable Collagen MatrixACTIVE_NOT_RECRUITINGNCT07546279The Use of Two Bone Substitutes in Adjunct to EMD for the Treatment of One- and Two-wall Intrabony Defects.RECRUITINGNCT07613775Volume-Stable Collagen Matrix Versus Subepithelial Connective Tissue Graft for Multiple Gingival RecessionsNOT_YET_RECRUITINGNCT07713199Free Soft Tissue Grafts FSTG) Using Autograft Palatal Donor Tissue vs. Xenograft Collagen Matrix (Zderm™)NOT_YET_RECRUITINGNCT07748871Ovate Pontic Versus Essix Provisional After Tooth Extraction and Alveolar Ridge Preservation (Pontic-Essix)NOT_YET_RECRUITINGNCT07782125Volume-Stable Collagen Matrix vs. Connective Tissue Graft for Peri-Implant Soft Tissue DefectsRECRUITING

Other records listing Collagen Matrix, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K251191Collagen Dura Regeneration Membrane - RepairK243071Bovine Dermis Collagen Dermal MatrixK242302RejuvaKnee™ Collagen Meniscus ImplantK233203Soft Tissue Augmentation Resorbable MatrixK240424Mineral Collagen Composite Bioactive Moldable Bone Graft MatrixK231942Mineral Collagen Composite Bioactive Extra Moldable

View all 16 devices →

Related Devices (Code: KGN)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260596Collagen Wound PowderVentris MedicalK260669Endoform Dermal TemplateAroa Biosurgery , Ltd.K253521ECMT-100 WMDEcm Therapeutics, Inc.K253204CatalyzeBioTissue Holdings, Inc.K254034Roosin Collagen PowderRoosin Medical Co., Ltd.K253974Roosin Collagen DressingRoosin Medical Co., Ltd.

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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