Product Code: NPL FDA class 2 21 CFR 872.3930

Barrier, Animal Source, Intraoral

Dental

The animal-source intraoral barrier is a dental implant device made of animal-derived materials such as collagen, intended to aid in guided tissue and bone regeneration procedures and to act as a stable barrier for containment of bone graft materials around implants. It is classified as FDA Class 2 under regulation 872.3930 in the Dental specialty, requiring 510(k) clearance, and carries an implant flag. Product code NPL is not eligible for third-party review.

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510(k)s

FEI Numbers

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Years Active

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Basic Information

Product Code: NPL
Device Class: FDA class 2
Regulation Number: 872.3930
Medical Specialty: Dental
Review Panel: DE
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✓

Implant

✗

Life Sustain/Support

✗

Third Party

—

Summary Malfunction Reporting

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.

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 57 510(k) clearances via K numbers.

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