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 |
| K212509 | Datum Dental Ltd. | OSSIX Breeze | 07/18/2022 |
| 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 |
| K212463 | Geistlich Pharma AG | Geistlich Bio-Gide, Geistlich Bio-Gide Shape, Geistlich Bio-Gide Compressed, Geistlich Bio-Gide Perio, Geistlich Combi-Kit Collagen and Geistlich Perio-System Combi Pack | 04/05/2022 |
| K192042 | Geistlich Pharma AG | Geistlich Bio-Gide, Geistlich Bio-Gide Shape, Geistlich Bio-Gide Compressed, Geistlich Bio-Gide Perio, Geistlich Combi-Kit Collagen, Geistlich Perio-System Combi-Pack, Geistlich Mucograft and Geistlich Mucograft Seal | 08/29/2019 |
| 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 |
| K210280 | Geistlich Pharma AG | Geistlich Mucograft«, Geistlich Mucograft« Seal | 03/03/2021 |
| 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 |
| K213904 | Kerecis | Kerecis Oral | 09/30/2022 |
| K192612 | Kerecis Limited | Kerecis Gingiva Graft | 11/13/2020 |
| 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 |
| K201241 | Orthocell Ltd | Striate+Ö | 01/11/2021 |
| 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 |
| K230091 | Purgo Biologics Inc. | THE Cover | 10/06/2023 |
| K223912 | SigmaGraft Inc. | InterCollagen« Guide | 08/17/2023 |
| K200623 | Sk bioland Co., Ltd. | OssGuide | 10/02/2020 |
| K073097 | TUTOGEN MEDICAL U.S., INC. | TUTODENT DENTAL MEMBRANE | 05/12/2008 |
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