FDA Product Code
FDA Product Code NPL — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Dental
- 21 CFR Citation
- 872.3930
510(k) Clearances — 57 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K242817 | Jason membrane | Botiss Biomaterials GmbH | 2025-12-12 | Traditional | PDF ↗ |
| K250512 | Augmented Gingival Matrix | Neo Modulus (Suzhou) Medical Sci-Tech Co., Ltd. | 2025-12-05 | Traditional | PDF ↗ |
| K252253 | Geistlich Mucograft® /Geistlich Mucograft® Seal; Geistlich Fibro-Gide® | Geistlich Pharma AG | 2025-11-25 | Traditional | PDF ↗ |
| K251062 | Geistlich 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 Pack | Geistlich Pharma AG | 2025-08-14 | Traditional | PDF ↗ |
| K250833 | SwissMembrane X; SwissMembrane X Socket | Geistlich Pharma AG | 2025-04-15 | Special | PDF ↗ |
| K233203 | Soft Tissue Augmentation Resorbable Matrix | Collagen Matrix, Inc. | 2024-05-01 | Traditional | PDF ↗ |
| K231513 | Oral Matrix | Beijing Biosis Healing Biolog Ical Technology Co., Ltd. | 2024-02-16 | Traditional | PDF ↗ |
| K231305 | Endoform Dental Membrane | Aroa Biosurgery , Ltd. | 2024-01-23 | Traditional | PDF ↗ |
| K230091 | THE Cover | Purgo Biologics, Inc. | 2023-10-06 | Traditional | PDF ↗ |
| K223912 | InterCollagen® Guide | Sigmagraft, Inc. | 2023-08-17 | Traditional | PDF ↗ |
| K213904 | Kerecis Oral | Kerecis | 2022-09-30 | Traditional | PDF ↗ |
| K212509 | OSSIX Breeze | Datum Dental, Ltd. | 2022-07-18 | Traditional | PDF ↗ |
| K212463 | 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 | Geistlich Pharma AG | 2022-04-05 | Traditional | PDF ↗ |
| K210280 | Geistlich Mucograft®, Geistlich Mucograft® Seal | Geistlich Pharma AG | 2021-03-03 | Special | PDF ↗ |
| K201241 | Striate+ | Orthocell, Ltd. | 2021-01-11 | Traditional | PDF ↗ |
| K192612 | Kerecis Gingiva Graft | Kerecis Limited | 2020-11-13 | Traditional | PDF ↗ |
| K200623 | OssGuide | Sk Bioland Co., Ltd. | 2020-10-02 | Traditional | PDF ↗ |
| K192042 | 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 | Geistlich Pharma AG | 2019-08-29 | Special | PDF ↗ |
| K173562 | Straumann Jason Membrane | Institut Straumann AG | 2018-07-09 | Traditional | PDF ↗ |
| K171050 | Geistlich Fibro-Gide | Geistlich Pharma AG | 2017-11-09 | Traditional | PDF ↗ |
| K171643 | Geistlich Bio-Gide Shape, Geistlich Bio-Gide Compressed | Geistlich Pharma AG | 2017-10-30 | Traditional | PDF ↗ |
| K161762 | DynaMatrix/Dynamatrix Plus | Cook Biotech Incorporated | 2017-01-13 | Special | PDF ↗ |
| K153549 | OSSIX VOLUMAX | Datum Dental, Ltd. | 2016-08-04 | Traditional | PDF ↗ |
| K160281 | OSSIX PLUS | Datum Dental, Ltd. | 2016-08-04 | Traditional | PDF ↗ |
| K160474 | DSM Biomedical Porcine Pericardium Dental Membrane | Kensey Nash Corporation Dba Dsm Biomedical | 2016-06-07 | Traditional | PDF ↗ |
| K141177 | VITALA PORCINE DERIVED COLLAGEN MEMBRANE | Osteogenics Biomedical, Inc. (Formerly Obi Biologi | 2015-09-15 | Traditional | PDF ↗ |
| K142496 | Collagen Dental Membrane - Conformable IIBP | Collagen Matrix, Inc. | 2014-11-24 | Traditional | PDF ↗ |
| K141909 | COLLAGEN DENTAL MEMBRANE - CONFORMABLE PP | Collagen Matrix, Inc. | 2014-11-05 | Traditional | PDF ↗ |
| K133507 | GUIDOSS | Nibec Co., Ltd. | 2014-11-05 | Traditional | PDF ↗ |
| K140518 | GEISTLICH MUCOGRAFT: 15 X 20 MM, 20 X 30 MM, 8 MM DIAMETER | Geistlich Pharma AG | 2014-07-18 | Traditional | PDF ↗ |
| K123697 | MATRICEL DENTAL BARRIER MEMBRANE | Matricel GmbH | 2014-02-24 | Traditional | PDF ↗ |
| K121310 | MESOTHELIUM DENTAL MEMBRANE | Kensey Nash Corporation | 2013-07-11 | Traditional | PDF ↗ |
| K100695 | COLLADENTAL BARRIER | Collamatrix, Inc. | 2013-01-03 | Traditional | PDF ↗ |
| K103087 | COVAMAX RESORBABLE COLLAGEN MEMBRANE | Biom'Up Sas | 2011-08-26 | Traditional | PDF ↗ |
| K110600 | COLLAGEN DENTAL MAMBRANE - PORCINE TYPE I COLLAGEN | Collagen Matrix, Inc. | 2011-07-29 | Traditional | PDF ↗ |
| K101453 | VITALA NATURAL RESORBABLE COLLAGEN MEMBRANE | Obi Biologics, Inc. | 2011-07-21 | Traditional | PDF ↗ |
| K102307 | GENOSS COLLAGEN MEMBRANE MODEL GCM1020, GCM3040 TOTAL 6 MODELS | Genoss Co., Ltd. | 2011-05-04 | Traditional | PDF ↗ |
| K102531 | MUCOGRAFT | Ed. Geistlich Soehne AG Fur Chemische Industrie | 2010-11-17 | Traditional | PDF ↗ |
| K100156 | COLLAGEN DENTAL MEMBRANE V | Collagen Matrix, Inc. | 2010-08-11 | Traditional | PDF ↗ |
| K091192 | KENSEY NASH P1076 COLLAGEN DENTAL MEMBRANE, MODEL 20655-XX | Kensey Nash Corp. | 2009-11-02 | Traditional | PDF ↗ |
| K090919 | KENSEY NASH FIBRILLAR COLLAGEN DENTAL MEMBRANE | Kensey Nash Corp. | 2009-10-02 | Traditional | PDF ↗ |
| K090216 | COLLAGEN DENTAL MEMBRANE IV | Collagen Matrix, Inc. | 2009-09-18 | Traditional | PDF ↗ |
| K082058 | DYNAMATRIX | Cook Biotech, Inc. | 2008-10-02 | Traditional | PDF ↗ |
| K073685 | OTA COLLAGEN BIOMATERIAL | Osseous Technologies of America | 2008-08-29 | Traditional | PDF ↗ |
| K073711 | MUCOGRAFT COLLAGEN MATRIX | Ed. Geistlich Soehne AG Fuer Chemische Industrie | 2008-05-30 | Traditional | PDF ↗ |
| K073097 | TUTODENT DENTAL MEMBRANE | Tutogen Medical U.S., Inc. | 2008-05-12 | Traditional | PDF ↗ |
| K071555 | FORTAGEN ORAL MEMBRANE | Organogenesis, Inc. | 2007-08-30 | Traditional | PDF ↗ |
| K062846 | COLLAGEN DENTAL MEMBRANE III | Collagen Matrix, Inc. | 2006-10-13 | Special | PDF ↗ |
| K062881 | COLLAGEN DENTAL MENBRANE - CONFORMABLE II | Collagen Matrix, Inc. | 2006-10-11 | Special | PDF ↗ |
| K061244 | MUCOGRAFT | Ed. Geistlich Soehne AG Fuer Chemische Industrie | 2006-06-06 | Traditional | PDF ↗ |
| K053260 | OSSIX -PLUS | Colbar Lifescience , Ltd. | 2006-02-22 | Traditional | PDF ↗ |
| K050446 | BIO-GIDE RESORBABLE BILAYER MEMBRANE FOR GUIDED TISSUE AND BONE | Ed. Geistlich Soehne AG Fuer Chemische Industrie | 2005-08-09 | Traditional | PDF ↗ |
| K042197 | BIO-GIDE RESORBABLE BILAYER MEMBRANE FOR GUIDED TISSUE AND BONE REGENERATION | Ed. Geistlich Soehne AG Fuer Chemische Industrie | 2004-11-15 | Traditional | PDF ↗ |
| K012423 | MUCOGRAFT | Ed. Geistlich Soehne AG Fuer Chemische Industrie | 2003-01-24 | Traditional | PDF ↗ |
| K010952 | SURGISIS GUIDED TISSUE REGENERATION MATRIX | Cook Biotech, Inc. | 2002-06-10 | Traditional | PDF ↗ |
| K011695 | COLLAGEN DENTAL MEMBRANE | Collagen Matrix, Inc. | 2001-08-07 | Traditional | PDF ↗ |
| K003339 | COLLAGEN PERIODONTAL MEMBRANE | Collagen Matrix, Inc. | 2001-01-08 | Traditional | PDF ↗ |
Product code NPL · Class II · Dental. Data: openFDA.