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FDA 510(k)

BIO-GIDE RESORBABLE BILAYER MEMBRANE FOR GUIDED TISSUE AND BONE REGENERATION

K-Number: K042197 · 2004-11-15

ApplicantEd. Geistlich Soehne AG Fuer Chemische Industrie
Decision Date2004-11-15
Product CodeNPL
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

BIO-GIDE RESORBABLE BILAYER MEMBRANE FOR GUIDED TISSUE AND BONE REGENERATION is the device name listed in this FDA 510(k) record. The listed applicant is Ed. Geistlich Soehne AG Fuer Chemische Industrie. It received FDA 510(k) clearance on 2004-11-15 under 510(k) number K042197. 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 BIO-GIDE RESORBABLE BILAYER MEMBRANE FOR GUIDED TISSUE AND BONE REGENERATION?

BIO-GIDE RESORBABLE BILAYER MEMBRANE FOR GUIDED TISSUE AND BONE REGENERATION is a medical device that received FDA 510(k) clearance on 2004-11-15. The listed applicant is Ed. Geistlich Soehne AG Fuer Chemische Industrie. The 510(k) number is K042197.

When did BIO-GIDE RESORBABLE BILAYER MEMBRANE FOR GUIDED TISSUE AND BONE REGENERATION receive FDA 510(k) clearance?

BIO-GIDE RESORBABLE BILAYER MEMBRANE FOR GUIDED TISSUE AND BONE REGENERATION received FDA 510(k) clearance on 2004-11-15, under 510(k) number K042197.

Who is the listed applicant for BIO-GIDE RESORBABLE BILAYER MEMBRANE FOR GUIDED TISSUE AND BONE REGENERATION?

The FDA 510(k) record lists Ed. Geistlich Soehne AG Fuer Chemische Industrie as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BIO-GIDE RESORBABLE BILAYER MEMBRANE FOR GUIDED TISSUE AND BONE REGENERATION?

The FDA product code for BIO-GIDE RESORBABLE BILAYER MEMBRANE FOR GUIDED TISSUE AND BONE REGENERATION is NPL.

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Other records listing Ed. Geistlich Soehne AG Fuer Chemische Industrie 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.

K092428BIO-OSS COLLAGENK073711MUCOGRAFT COLLAGEN MATRIXK061244MUCOGRAFTK050446BIO-GIDE RESORBABLE BILAYER MEMBRANE FOR GUIDED TISSUE AND BONEK012423MUCOGRAFT

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

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

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