510(k) Report

Devices descending from K042197

58 later devices reach Bio-Gide Resorbable Bilayer Membrane for Guided Tissue and Bone Regeneration through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K201241Striate+™Orthocell, Ltd.20210—
+1K192042Geistlich Bio-Gide, Geistlich Bio-Gide Shape, Geistlich Bio-Gide Compressed, Geistlich…Geistlich Pharma AG20199—
+1K160474DSM Biomedical Porcine Pericardium Dental MembraneKensey Nash Corporation Dba Dsm Biomedical20160—
+1K141909Collagen Dental Membrane - Conformable PPCollagen Matrix, Inc.20140—
+1K123697Matricel Dental Barrier MembraneMatricel GmbH20140—
+1K100695Colladental BarrierCollamatrix, Inc.20131—
+1K112572Geistlich Combi-Kit CollegenGeistlich Pharma AG201123—
+1K112575Geistlich Perio-System Combi-Pack , Geistlich Bio-Gide PerioGeistlich Pharma AG201111—
+1K103087Covamax Resorbable Collagen MembraneBiom'Up Sas201101
+1K073711Mucograft Collagen MatrixEd. Geistlich Soehne AG Fuer Chemische Industrie200815—
+1K061244MucograftEd. Geistlich Soehne AG Fuer Chemische Industrie200616—
+1K050446Bio-Gide Resorbable Bilayer Membrane for Guided Tissue and BoneEd. Geistlich Soehne AG Fuer Chemische Industrie200553—
+2K230091THE CoverPurgo Biologics, Inc.20230—
+2K213904Kerecis OralKerecis20220—
+2K212463Geistlich Bio-Gide, Geistlich Bio-Gide Shape, Geistlich Bio-Gide Compressed, Geistlich…Geistlich Pharma AG20223—
+2K210280Geistlich Mucograft®, Geistlich Mucograft® SealGeistlich Pharma AG20213—
+2K200623OssGuideSk Bioland Co., Ltd.20200—
+2K171643Geistlich Bio-Gide Shape, Geistlich Bio-Gide CompressedGeistlich Pharma AG201710—
+2K133507GuidossNibec Co., Ltd.20140—
+2K140518Geistlich Mucograft: 15 X 20 MM, 20 X 30 MM, 8 MM DiameterGeistlich Pharma AG201410—
+2K132325Guidor Bioresorbable Matrix BarrierSunstar Americas, Inc.20130—
+2K121310Mesothelium Dental MembraneKensey Nash Corporation20130—
+2K122894Geistlich Bio-Oss, Geistlich Bio-Oss Collagen, Geistlich Combi-Kit Collagen, Geistlich…Geistlich Pharma AG201321—
+2K120601Geistlich Bio-Oss Pen (0.25 G, 0.25-1.0MM Granules), Geistlich Bio-Oss Pen (0.5 G…Geistlich Pharma AG201216
+2K101453Vitala Natural Resorbable Collagen MembraneObi Biologics, Inc.20114—
+2K102531MucograftEd. Geistlich Soehne AG Fur Chemische Industrie201013—
+2K100156Collagen Dental Membrane VCollagen Matrix, Inc.201016
+2K091192Kensey Nash P1076 Collagen Dental Membrane, Model 20655-XXKensey Nash Corp.20090—
+2K090919Kensey Nash Fibrillar Collagen Dental MembraneKensey Nash Corp.200903
+2K090216Collagen Dental Membrane IVCollagen Matrix, Inc.20093—
+2K082111Straumann MembragelInstitut Straumann AG20091—
+2K071555Fortagen Oral MembraneOrganogenesis, Inc.20071—
+3K253317Cytrans™ ElashieldGC America, Inc.20260—
+3K253723BOSSMedpark Co., Ltd.20260—
+3K250512Augmented Gingival MatrixNeo Modulus (Suzhou) Medical Sci-Tech Co., Ltd.20250—
+3K252253Geistlich Mucograft® /Geistlich Mucograft® Seal; Geistlich Fibro-Gide®Geistlich Pharma AG20250—
+3K251062Geistlich Bio-Gide; Geistlich Bio-Gide® Shape; Geistlich Bio-Gide® Compressed; Geistlich…Geistlich Pharma AG20250—
+3K251786Geistlich Bio-Oss®; Geistlich Bio-Oss Pen®Geistlich Pharma AG20250—
+3K250833SwissMembrane X; SwissMembrane X SocketGeistlich Pharma AG20250—
+3K242510Geistlich Bio-Flow®Geistlich Pharma AG20250—
+3K230305THE Graft CollagenPurgo Biologics, Inc.20240—
+3K240661Geistlich Bio-Oss®Geistlich Pharma AG20242—
+3K233203Soft Tissue Augmentation Resorbable MatrixCollagen Matrix, Inc.20240—
+3K231672S1Medpark Co., Ltd.20230—
+3K211551Wishbone HAWishbone SA20210—
+3K192612Kerecis Gingiva GraftKerecis Limited20200—
+3K193212DSM Biomedical Dental Bone Graft PlusDsm Biomedical20200—
+3K173594Straumann ceraboneInstitut Straumann AG20180—
+3K171050Geistlich Fibro-GideGeistlich Pharma AG20171—
+3K163714Ossix BoneDatum Dental, Ltd.20170—
+3K141177Vitala Porcine Derived Collagen MembraneOsteogenics Biomedical, Inc. (Formerly Obi Biologi20153—
+3K142496Collagen Dental Membrane - Conformable IIBPCollagen Matrix, Inc.20140—
+3K102307Genoss Collagen Membrane Model GCM1020, GCM3040 Total 6 ModelsGenoss Co., Ltd.20110—
+3K101956Straumann MembragelStraumann USA (On Behalf of Institut Straumann Ag)20100—
+4K251613SwissGraft XGeistlich Pharma AG20250—
+4K173562Straumann Jason MembraneInstitut Straumann AG20182—
+5K242817Jason membraneBotiss Biomaterials GmbH20250—
+5K223912InterCollagen® GuideSigmagraft, Inc.20230—