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FDA 510(k)

COLLAGEN DENTAL MEMBRANE IV

K-Number: K090216 · 2009-09-18

ApplicantCollagen Matrix, Inc.
Decision Date2009-09-18
Product CodeNPL
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

COLLAGEN DENTAL MEMBRANE IV 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 2009-09-18 under 510(k) number K090216. The device is classified under product code NPL. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COLLAGEN DENTAL MEMBRANE IV?

COLLAGEN DENTAL MEMBRANE IV is a medical device that received FDA 510(k) clearance on 2009-09-18. The listed applicant is Collagen Matrix, Inc.. The 510(k) number is K090216.

When did COLLAGEN DENTAL MEMBRANE IV receive FDA 510(k) clearance?

COLLAGEN DENTAL MEMBRANE IV received FDA 510(k) clearance on 2009-09-18, under 510(k) number K090216.

Who is the listed applicant for COLLAGEN DENTAL MEMBRANE IV?

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 MEMBRANE IV?

The FDA product code for COLLAGEN DENTAL MEMBRANE IV is NPL.

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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

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Related Devices (Code: NPL)

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.

K242817Jason membraneBotiss Biomaterials GmbHK250512Augmented Gingival MatrixNeo Modulus (Suzhou) Medical Sci-Tech Co., Ltd.K252253Geistlich Mucograft® /Geistlich Mucograft® Seal; Geistlich Fibro-Gide®Geistlich Pharma AGK251062Geistlich Bio-Gide; Geistlich Bio-Gide® Shape; Geistlich Bio-Gide® Compressed; Geistlich Bio-Gide® Forte; Geistlich Bio-Gide® Perio; Geistlich Combi-Kit Collagen®; Geistlich Perio-System Combi PackGeistlich Pharma AGK250833SwissMembrane X; SwissMembrane X SocketGeistlich Pharma AGK233203Soft Tissue Augmentation Resorbable MatrixCollagen Matrix, 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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