Atlas FDA

NPL

57 FDA 510(k) clearances · Product code

203 daysmedian time to decision
437 days90th percentile
57clearances measured

FDA profile

Official device name
Barrier, Animal Source, Intraoral
Device class
Class II (moderate risk)
Regulation
21 CFR 872.3930
Medical specialty
Dental
Flags
Implant
FDA definition
An animal source dental barrier is an animal-derived material device, such as collagen, intended to aid in guided tissue/bone regeneration procedures and to act as a stable barrier for the containment of bone graft materials when placed around implants.
Adverse events (MAUDE)
2017: 18 · 2018: 14 · 2019: 22 · 2022: 19 · 2024: 20 · 2025: 39
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
Jason membrane (K242817)Botiss Biomaterials GmbH2025-12-12
Augmented Gingival Matrix (K250512)Neo Modulus (Suzhou) Medical Sci-Tech Co., Ltd.2025-12-05
Geistlich Mucograft® /Geistlich Mucograft® Seal; Geistlich Fibro-Gide® (K252253)Geistlich Pharma AG2025-11-25
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 (K251062)Geistlich Pharma AG2025-08-14
SwissMembrane X; SwissMembrane X Socket (K250833)Geistlich Pharma AG2025-04-15
Soft Tissue Augmentation Resorbable Matrix (K233203)Collagen Matrix, Inc.2024-05-01
Oral Matrix (K231513)Beijing Biosis Healing Biolog Ical Technology Co., Ltd.2024-02-16
Endoform Dental Membrane (K231305)Aroa Biosurgery , Ltd.2024-01-23
THE Cover (K230091)Purgo Biologics, Inc.2023-10-06
InterCollagen® Guide (K223912)Sigmagraft, Inc.2023-08-17
Kerecis Oral (K213904)Kerecis2022-09-30
OSSIX Breeze (K212509)Datum Dental, Ltd.2022-07-18
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 (K212463)Geistlich Pharma AG2022-04-05
Geistlich Mucograft®, Geistlich Mucograft® Seal (K210280)Geistlich Pharma AG2021-03-03
Striate+™ (K201241)Orthocell, Ltd.2021-01-11
Kerecis Gingiva Graft (K192612)Kerecis Limited2020-11-13
OssGuide (K200623)Sk Bioland Co., Ltd.2020-10-02
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 (K192042)Geistlich Pharma AG2019-08-29
Straumann Jason Membrane (K173562)Institut Straumann AG2018-07-09
Geistlich Fibro-Gide (K171050)Geistlich Pharma AG2017-11-09
Geistlich Bio-Gide Shape, Geistlich Bio-Gide Compressed (K171643)Geistlich Pharma AG2017-10-30
DynaMatrix/Dynamatrix Plus (K161762)Cook Biotech Incorporated2017-01-13
OSSIX PLUS (K160281)Datum Dental, Ltd.2016-08-04
OSSIX VOLUMAX (K153549)Datum Dental, Ltd.2016-08-04
DSM Biomedical Porcine Pericardium Dental Membrane (K160474)Kensey Nash Corporation Dba Dsm Biomedical2016-06-07
VITALA PORCINE DERIVED COLLAGEN MEMBRANE (K141177)Osteogenics Biomedical, Inc. (Formerly Obi Biologi2015-09-15
Collagen Dental Membrane - Conformable IIBP (K142496)Collagen Matrix, Inc.2014-11-24
COLLAGEN DENTAL MEMBRANE - CONFORMABLE PP (K141909)Collagen Matrix, Inc.2014-11-05
GUIDOSS (K133507)Nibec Co., Ltd.2014-11-05
GEISTLICH MUCOGRAFT: 15 X 20 MM, 20 X 30 MM, 8 MM DIAMETER (K140518)Geistlich Pharma AG2014-07-18
MATRICEL DENTAL BARRIER MEMBRANE (K123697)Matricel GmbH2014-02-24
MESOTHELIUM DENTAL MEMBRANE (K121310)Kensey Nash Corporation2013-07-11
COLLADENTAL BARRIER (K100695)Collamatrix, Inc.2013-01-03
COVAMAX RESORBABLE COLLAGEN MEMBRANE (K103087)Biom'Up Sas2011-08-26
COLLAGEN DENTAL MAMBRANE - PORCINE TYPE I COLLAGEN (K110600)Collagen Matrix, Inc.2011-07-29
VITALA NATURAL RESORBABLE COLLAGEN MEMBRANE (K101453)Obi Biologics, Inc.2011-07-21
GENOSS COLLAGEN MEMBRANE MODEL GCM1020, GCM3040 TOTAL 6 MODELS (K102307)Genoss Co., Ltd.2011-05-04
MUCOGRAFT (K102531)Ed. Geistlich Soehne AG Fur Chemische Industrie2010-11-17
COLLAGEN DENTAL MEMBRANE V (K100156)Collagen Matrix, Inc.2010-08-11
KENSEY NASH P1076 COLLAGEN DENTAL MEMBRANE, MODEL 20655-XX (K091192)Kensey Nash Corp.2009-11-02
KENSEY NASH FIBRILLAR COLLAGEN DENTAL MEMBRANE (K090919)Kensey Nash Corp.2009-10-02
COLLAGEN DENTAL MEMBRANE IV (K090216)Collagen Matrix, Inc.2009-09-18
DYNAMATRIX (K082058)Cook Biotech, Inc.2008-10-02
OTA COLLAGEN BIOMATERIAL (K073685)Osseous Technologies of America2008-08-29
MUCOGRAFT COLLAGEN MATRIX (K073711)Ed. Geistlich Soehne AG Fuer Chemische Industrie2008-05-30
TUTODENT DENTAL MEMBRANE (K073097)Tutogen Medical U.S., Inc.2008-05-12
FORTAGEN ORAL MEMBRANE (K071555)Organogenesis, Inc.2007-08-30
COLLAGEN DENTAL MEMBRANE III (K062846)Collagen Matrix, Inc.2006-10-13
COLLAGEN DENTAL MENBRANE - CONFORMABLE II (K062881)Collagen Matrix, Inc.2006-10-11
MUCOGRAFT (K061244)Ed. Geistlich Soehne AG Fuer Chemische Industrie2006-06-06
OSSIX -PLUS (K053260)Colbar Lifescience , Ltd.2006-02-22
BIO-GIDE RESORBABLE BILAYER MEMBRANE FOR GUIDED TISSUE AND BONE (K050446)Ed. Geistlich Soehne AG Fuer Chemische Industrie2005-08-09
BIO-GIDE RESORBABLE BILAYER MEMBRANE FOR GUIDED TISSUE AND BONE REGENERATION (K042197)Ed. Geistlich Soehne AG Fuer Chemische Industrie2004-11-15
MUCOGRAFT (K012423)Ed. Geistlich Soehne AG Fuer Chemische Industrie2003-01-24
SURGISIS GUIDED TISSUE REGENERATION MATRIX (K010952)Cook Biotech, Inc.2002-06-10
COLLAGEN DENTAL MEMBRANE (K011695)Collagen Matrix, Inc.2001-08-07
COLLAGEN PERIODONTAL MEMBRANE (K003339)Collagen Matrix, Inc.2001-01-08

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Every clearance here is in the API, with alerts when new ones post.