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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 a medical device manufactured by Collagen Matrix, Inc.. It received FDA 510(k) clearance on 2016-06-23 under approval 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. It is manufactured by Collagen Matrix, Inc.. The 510(k) number is K152600.

When was Collagen Dental Wound Dressings approved by the FDA?

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

What company makes Collagen Dental Wound Dressings?

Collagen Dental Wound Dressings is manufactured by Collagen Matrix, Inc..

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

NCT06420323 NovoX®Cup as Primary Dressing After Breast Reduction ACTIVE_NOT_RECRUITING NCT07613775 Volume-Stable Collagen Matrix Versus Subepithelial Connective Tissue Graft for Multiple Gingival Recessions NOT_YET_RECRUITING NCT07040683 Negative Pressure Wound Therapy for Split Thickness Skin Grafting to the Lower Leg After Excision of Skin Tumour: A Multicentre Randomised Study RECRUITING NCT07607366 Effects of Negative Pressure Wound Bandaging After Mastectomy RECRUITING NCT07605286 Soft Tissue Augmentation Around Dental Implants COMPLETED NCT07409571 Palatal Wound Healing After Free Gingival Graft Surgery RECRUITING

Related PubMed Literature

PMID: 40574448 [Research and Discussion on the Whole Lifecycle Supervision of Typical Class Ⅱ Wound Dressing Products]. Zhongguo yi liao qi xie za zhi = Chinese journal of medical instrumentation (2025)

Other Devices by Collagen Matrix, Inc.

K171008Anorganic Bone Mineral with Collagen in Delivery Applicator K170541Anorganic Bone Mineral in Delivery Applicator K170656Reinforced Flexible Collagen Nerve Cuff K162158Porcine Anorganic Bone Mineral in Delivery Applicator K182074Mineral Collagen Composite Bioactive Moldable K201859Porcine Mineral Collagen Composite Moldable

View all 16 devices →

Related Devices (Code: KGN)

K160136Flowable Wound MatrixCook Biotech Incorporated K153754MicroMatrixAcell, Inc. K153690PriMatrix Dermal Repair ScaffoldTei Biosciences, Inc. K172010gel-e BandageGel-E, Inc. (Formerly Remedium Technologies, Inc.) K171842Geistlich Wound MatrixGeistlich Pharma AG K172399MicroMatrixAcell, Inc.

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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