Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
NPL — Predicate Candidate Screening
57 FDA 510(k) clearances under this product code; the 50 most recent screened below.
203 daysmedian FDA review time
437 days90th percentile
57clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K242817 | Jason membrane | Botiss Biomaterials GmbH | 2025-12-12 | 450 | 0 |
| K250512 | Augmented Gingival Matrix | Neo Modulus (Suzhou) Medical Sci-Tech Co., Ltd. | 2025-12-05 | 287 | 0 |
| K252253 | Geistlich Mucograft® /Geistlich Mucograft® Seal; Geistlich F | Geistlich Pharma AG | 2025-11-25 | 127 | 0 |
| K251062 | Geistlich Bio-Gide; Geistlich Bio-Gide® Shape; Geistlich Bio | Geistlich Pharma AG | 2025-08-14 | 132 | 0 |
| K250833 | SwissMembrane X; SwissMembrane X Socket | Geistlich Pharma AG | 2025-04-15 | 27 | 0 |
| K233203 | Soft Tissue Augmentation Resorbable Matrix | Collagen Matrix, Inc. | 2024-05-01 | 216 | 0 |
| K231513 | Oral Matrix | Beijing Biosis Healing Biolog Ical Technology Co., Ltd. | 2024-02-16 | 267 | 0 |
| K231305 | Endoform Dental Membrane | Aroa Biosurgery , Ltd. | 2024-01-23 | 263 | 0 |
| K230091 | THE Cover | Purgo Biologics, Inc. | 2023-10-06 | 267 | 0 |
| K223912 | InterCollagen® Guide | Sigmagraft, Inc. | 2023-08-17 | 231 | 0 |
| K213904 | Kerecis Oral | Kerecis | 2022-09-30 | 290 | 0 |
| K212509 | OSSIX Breeze | Datum Dental, Ltd. | 2022-07-18 | 343 | 0 |
| K212463 | Geistlich Bio-Gide, Geistlich Bio-Gide Shape, Geistlich Bio- | Geistlich Pharma AG | 2022-04-05 | 242 | 0 |
| K210280 | Geistlich Mucograft®, Geistlich Mucograft® Seal | Geistlich Pharma AG | 2021-03-03 | 30 | 0 |
| K201241 | Striate+™ | Orthocell, Ltd. | 2021-01-11 | 248 | 0 |
| K192612 | Kerecis Gingiva Graft | Kerecis Limited | 2020-11-13 | 420 | 0 |
| K200623 | OssGuide | Sk Bioland Co., Ltd. | 2020-10-02 | 207 | 0 |
| K192042 | Geistlich Bio-Gide, Geistlich Bio-Gide Shape, Geistlich Bio- | Geistlich Pharma AG | 2019-08-29 | 29 | 0 |
| K173562 | Straumann Jason Membrane | Institut Straumann AG | 2018-07-09 | 234 | 0 |
| K171050 | Geistlich Fibro-Gide | Geistlich Pharma AG | 2017-11-09 | 216 | 0 |
| K171643 | Geistlich Bio-Gide Shape, Geistlich Bio-Gide Compressed | Geistlich Pharma AG | 2017-10-30 | 150 | 0 |
| K161762 | DynaMatrix/Dynamatrix Plus | Cook Biotech Incorporated | 2017-01-13 | 200 | 0 |
| K160281 | OSSIX PLUS | Datum Dental, Ltd. | 2016-08-04 | 184 | 0 |
| K153549 | OSSIX VOLUMAX | Datum Dental, Ltd. | 2016-08-04 | 237 | 0 |
| K160474 | DSM Biomedical Porcine Pericardium Dental Membrane | Kensey Nash Corporation Dba Dsm Biomedical | 2016-06-07 | 109 | 0 |
| K141177 | VITALA PORCINE DERIVED COLLAGEN MEMBRANE | Osteogenics Biomedical, Inc. (Formerly Obi Biologi | 2015-09-15 | 496 | 0 |
| K142496 | Collagen Dental Membrane - Conformable IIBP | Collagen Matrix, Inc. | 2014-11-24 | 80 | 0 |
| K141909 | COLLAGEN DENTAL MEMBRANE - CONFORMABLE PP | Collagen Matrix, Inc. | 2014-11-05 | 113 | 0 |
| K133507 | GUIDOSS | Nibec Co., Ltd. | 2014-11-05 | 356 | 0 |
| K140518 | GEISTLICH MUCOGRAFT: 15 X 20 MM, 20 X 30 MM, 8 MM DIAMETER | Geistlich Pharma AG | 2014-07-18 | 140 | 0 |
| K123697 | MATRICEL DENTAL BARRIER MEMBRANE | Matricel GmbH | 2014-02-24 | 448 | 0 |
| K121310 | MESOTHELIUM DENTAL MEMBRANE | Kensey Nash Corporation | 2013-07-11 | 436 | 0 |
| K100695 | COLLADENTAL BARRIER | Collamatrix, Inc. | 2013-01-03 | 1029 | 0 |
| K103087 | COVAMAX RESORBABLE COLLAGEN MEMBRANE | Biom'Up Sas | 2011-08-26 | 311 | 1 |
| K110600 | COLLAGEN DENTAL MAMBRANE - PORCINE TYPE I COLLAGEN | Collagen Matrix, Inc. | 2011-07-29 | 149 | 0 |
| K101453 | VITALA NATURAL RESORBABLE COLLAGEN MEMBRANE | Obi Biologics, Inc. | 2011-07-21 | 422 | 0 |
| K102307 | GENOSS COLLAGEN MEMBRANE MODEL GCM1020, GCM3040 TOTAL 6 MODE | Genoss Co., Ltd. | 2011-05-04 | 261 | 0 |
| K102531 | MUCOGRAFT | Ed. Geistlich Soehne AG Fur Chemische Industrie | 2010-11-17 | 75 | 0 |
| K100156 | COLLAGEN DENTAL MEMBRANE V | Collagen Matrix, Inc. | 2010-08-11 | 203 | 0 |
| K091192 | KENSEY NASH P1076 COLLAGEN DENTAL MEMBRANE, MODEL 20655-XX | Kensey Nash Corp. | 2009-11-02 | 193 | 0 |
| K090919 | KENSEY NASH FIBRILLAR COLLAGEN DENTAL MEMBRANE | Kensey Nash Corp. | 2009-10-02 | 184 | 3 |
| K090216 | COLLAGEN DENTAL MEMBRANE IV | Collagen Matrix, Inc. | 2009-09-18 | 232 | 0 |
| K082058 | DYNAMATRIX | Cook Biotech, Inc. | 2008-10-02 | 73 | 0 |
| K073685 | OTA COLLAGEN BIOMATERIAL | Osseous Technologies of America | 2008-08-29 | 245 | 0 |
| K073711 | MUCOGRAFT COLLAGEN MATRIX | Ed. Geistlich Soehne AG Fuer Chemische Industrie | 2008-05-30 | 151 | 0 |
| K073097 | TUTODENT DENTAL MEMBRANE | Tutogen Medical U.S., Inc. | 2008-05-12 | 193 | 0 |
| K071555 | FORTAGEN ORAL MEMBRANE | Organogenesis, Inc. | 2007-08-30 | 84 | 0 |
| K062846 | COLLAGEN DENTAL MEMBRANE III | Collagen Matrix, Inc. | 2006-10-13 | 21 | 1 |
| K062881 | COLLAGEN DENTAL MENBRANE - CONFORMABLE II | Collagen Matrix, Inc. | 2006-10-11 | 15 | 0 |
| K061244 | MUCOGRAFT | Ed. Geistlich Soehne AG Fuer Chemische Industrie | 2006-06-06 | 34 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda