FDA 510(k) Applications for Medical Device Product Code "NPL"
(Barrier, Animal Source, Intraoral)

FDA 510(k) Number Applicant Device Name Decision Date
K103087 BIOM'UP SAS COVAMAX RESORBABLE COLLAGEN MEMBRANE 08/26/2011
K053260 COLBAR LIFESCIENCE LTD. OSSIX -PLUS 02/22/2006
K110600 COLLAGEN MATRIX, INC. COLLAGEN DENTAL MAMBRANE - PORCINE TYPE I COLLAGEN 07/29/2011
K011695 COLLAGEN MATRIX, INC. COLLAGEN DENTAL MEMBRANE 08/07/2001
K142496 COLLAGEN MATRIX, INC. Collagen Dental Membrane - Conformable IIBP 11/24/2014
K141909 COLLAGEN MATRIX, INC. COLLAGEN DENTAL MEMBRANE - CONFORMABLE PP 11/05/2014
K062846 COLLAGEN MATRIX, INC. COLLAGEN DENTAL MEMBRANE III 10/13/2006
K090216 COLLAGEN MATRIX, INC. COLLAGEN DENTAL MEMBRANE IV 09/18/2009
K100156 COLLAGEN MATRIX, INC. COLLAGEN DENTAL MEMBRANE V 08/11/2010
K062881 COLLAGEN MATRIX, INC. COLLAGEN DENTAL MENBRANE - CONFORMABLE II 10/11/2006
K003339 COLLAGEN MATRIX, INC. COLLAGEN PERIODONTAL MEMBRANE 01/08/2001
K100695 COLLAMATRIX, INC COLLADENTAL BARRIER 01/03/2013
K161762 COOK BIOTECH INCORPORATED DynaMatrix/Dynamatrix Plus 01/13/2017
K082058 COOK BIOTECH, INC. DYNAMATRIX 10/02/2008
K010952 COOK BIOTECH, INC. SURGISIS GUIDED TISSUE REGENERATION MATRIX 06/10/2002
K160281 Datum Dental Ltd. OSSIX PLUS 08/04/2016
K153549 Datum Dental Ltd. OSSIX VOLUMAX 08/04/2016
K050446 ED. GEISTLICH SOEHNE AG FUER CHEMISCHE INDUSTRIE BIO-GIDE RESORBABLE BILAYER MEMBRANE FOR GUIDED TISSUE AND BONE 08/09/2005
K042197 ED. GEISTLICH SOEHNE AG FUER CHEMISCHE INDUSTRIE BIO-GIDE RESORBABLE BILAYER MEMBRANE FOR GUIDED TISSUE AND BONE REGENERATION 11/15/2004
K012423 ED. GEISTLICH SOEHNE AG FUER CHEMISCHE INDUSTRIE MUCOGRAFT 01/24/2003
K061244 ED. GEISTLICH SOEHNE AG FUER CHEMISCHE INDUSTRIE MUCOGRAFT 06/06/2006
K073711 ED. GEISTLICH SOEHNE AG FUER CHEMISCHE INDUSTRIE MUCOGRAFT COLLAGEN MATRIX 05/30/2008
K102531 ED. GEISTLICH SOEHNE AG FUR CHEMISCHE INDUSTRIE MUCOGRAFT 11/17/2010
K171643 Geistlich Pharma AG Geistlich Bio-Gide Shape, Geistlich Bio-Gide Compressed 10/30/2017
K171050 Geistlich Pharma AG Geistlich Fibro-Gide 11/09/2017
K140518 GEISTLICH PHARMA AG GEISTLICH MUCOGRAFT: 15 X 20 MM, 20 X 30 MM, 8 MM DIAMETER 07/18/2014
K102307 GENOSS CO., LTD. GENOSS COLLAGEN MEMBRANE MODEL GCM1020, GCM3040 TOTAL 6 MODELS 05/04/2011
K173562 Institut Straumann AG Straumann Jason Membrane 07/09/2018
K090919 KENSEY NASH CORP. KENSEY NASH FIBRILLAR COLLAGEN DENTAL MEMBRANE 10/02/2009
K091192 KENSEY NASH CORP. KENSEY NASH P1076 COLLAGEN DENTAL MEMBRANE, MODEL 20655-XX 11/02/2009
K121310 KENSEY NASH CORPORATION MESOTHELIUM DENTAL MEMBRANE 07/11/2013
K160474 Kensey Nash Corporation dba DSM Biomedical DSM Biomedical Porcine Pericardium Dental Membrane 06/07/2016
K123697 MATRICEL GMBH MATRICEL DENTAL BARRIER MEMBRANE 02/24/2014
K133507 NIBEC CO LTD GUIDOSS 11/05/2014
K101453 OBI BIOLOGICS, INC. VITALA NATURAL RESORBABLE COLLAGEN MEMBRANE 07/21/2011
K071555 ORGANOGENESIS, INC. FORTAGEN ORAL MEMBRANE 08/30/2007
K073685 OSSEOUS TECHNOLOGIES OF AMERICA OTA COLLAGEN BIOMATERIAL 08/29/2008
K141177 OSTEOGENICS BIOMEDICAL, INC. (FORMERLY OBI BIOLOGI VITALA PORCINE DERIVED COLLAGEN MEMBRANE 09/15/2015
K073097 TUTOGEN MEDICAL U.S., INC. TUTODENT DENTAL MEMBRANE 05/12/2008


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