Product Code: NPM FDA class 2 21 CFR 872.3930

Bone Grafting Material, Animal Source

Dental

The animal-source bone grafting material for dental use is a naturally derived device such as collagen intended to fill, augment, or reconstruct periodontal or jaw bone defects following disease, trauma, or surgery. 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 NPM is not eligible for third-party review.

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510(k)s

FEI Numbers

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Basic Information

Product Code: NPM
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

A animal-source bone grafting material is a naturally-derived device, such as collagen, intended to fill, augment, or reconstruct periodontal defects and or bony defects of the upper or lower jaw.

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 40 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K253723	BOSS	Jun 16, 2026	Substantially Equivalent	Medpark Co., Ltd.
K251786	Geistlich Bio-Oss®; Geistlich Bio-Oss Pen®	Jul 11, 2025	Substantially Equivalent	Geistlich Pharma AG
K251613	SwissGraft X	Jun 26, 2025	Substantially Equivalent	Geistlich Pharma AG
K242510	Geistlich Bio-Flow®	Mar 07, 2025	Substantially Equivalent	Geistlich Pharma AG
K240133	Xenograft Bovine Bone Particulate	Aug 16, 2024	Substantially Equivalent	Collagen Solutions, LLC
K230305	THE Graft Collagen	Jul 24, 2024	Substantially Equivalent	Purgo Biologics, Inc.
K240661	Geistlich Bio-Oss®	Jul 12, 2024	Substantially Equivalent	Geistlich Pharma AG
K231672	S1	Oct 13, 2023	Substantially Equivalent	Medpark Co., Ltd.
K221808	InterOss Collagen	Mar 18, 2023	Substantially Equivalent	Sigmagraft, Inc.
K211551	Wishbone HA	Aug 20, 2021	Substantially Equivalent	Wishbone SA
K202183	Porcine Mineral Collagen Composite	Apr 02, 2021	Substantially Equivalent	Collagen Matrix, Inc.
K201859	Porcine Mineral Collagen Composite Moldable	Sep 11, 2020	Substantially Equivalent	Collagen Matrix, Inc.
K193212	DSM Biomedical Dental Bone Graft Plus	Sep 10, 2020	Substantially Equivalent	Dsm Biomedical
K191737	The Graft Bone Substitute	Feb 14, 2020	Substantially Equivalent	Purgo Biologics, Inc.
K173594	Straumann cerabone	Oct 19, 2018	Substantially Equivalent	Institut Straumann AG
K173188	The Graft Natural Bone Substitute	Jul 20, 2018	Substantially Equivalent	Purgo Biologics, Inc.
K171008	Anorganic Bone Mineral with Collagen in Delivery Applicator	Oct 30, 2017	Substantially Equivalent	Collagen Matrix, Inc.
K163714	OSSIX BONE	Jul 18, 2017	Substantially Equivalent	Datum Dental, Ltd.
K170541	Anorganic Bone Mineral in Delivery Applicator	Jul 07, 2017	Substantially Equivalent	Collagen Matrix, Inc.
K170245	DSM Biomedical Dental Bone Graft	May 16, 2017	Substantially Equivalent	Kensey Nash Corporation Dba Dsm Biomedical
K162158	Porcine Anorganic Bone Mineral in Delivery Applicator	Feb 09, 2017	Substantially Equivalent	Collagen Matrix, Inc.
K151542	A-Oss	Aug 03, 2016	Substantially Equivalent	Hiossen, Inc.
K150079	Regenomer® Syringe, Regenomer® Plug, Regenomer® Block	Dec 10, 2015	Substantially Equivalent	Nibec Co., Ltd.
K151209	InterOss	Nov 06, 2015	Substantially Equivalent	Sigmagraft, Inc.
K142040	OCS-B COLLAGEN	Jul 31, 2015	Substantially Equivalent	Nibec Co., Ltd.
K140021	TI-OSS	Jun 05, 2015	Substantially Equivalent	Chiyewon
K140714	PORCINE ANORGANIC BONE MINERAL	Jul 16, 2014	Substantially Equivalent	Collagen Matrix, Inc.
K123876	SYNERGY	May 22, 2014	Substantially Equivalent	Odontit S.A.
K122894	GEISTLICH BIO-OSS, GEISTLICH BIO-OSS COLLAGEN, GEISTLICH COMBI-KIT COLLAGEN, GEISTLICH PERIO SYSTEM COMBI PACK, GEISTLIC	Feb 15, 2013	Substantially Equivalent	Geistlich Pharma AG
K113246	OCS-B	Jan 16, 2013	Substantially Equivalent	Nibec Company, Limited
K120152	CERASORB PLUS	Aug 13, 2012	Substantially Equivalent	Riemser Arzneimittel AG
K120601	GEISTLICH BIO-OSS PEN (0.25 G, 0.25-1.0MM GRANULES), GEISTLICH BIO-OSS PEN (0.5 G, 0.25-1.0MM GRANULES), GEISTLICH BIO-O	May 24, 2012	Substantially Equivalent	Geistlich Pharma AG
K112572	GEISTLICH COMBI-KIT COLLEGEN	Dec 28, 2011	Substantially Equivalent	Geistlich Pharma AG
K112575	GEISTLICH PERIO-SYSTEM COMBI-PACK , GEISTLICH BIO-GIDE PERIO	Dec 27, 2011	Substantially Equivalent	Geistlich Pharma AG
K111816	EQUIMATRIX	Sep 29, 2011	Substantially Equivalent	Luitpold Pharmaceuticals, Inc.
K091424	OSTA MAXIGRO AND REGIGRO	Aug 18, 2010	Substantially Equivalent	Osta Technologies
K092428	BIO-OSS COLLAGEN	Mar 18, 2010	Substantially Equivalent	Ed. Geistlich Soehne AG Fuer Chemische Industrie
K090794	OSTEOTAPE	Dec 10, 2009	Substantially Equivalent	Impladent , Ltd.
K043034	OSTEOGUIDE ANORGANIC BONE MINERAL PRODUCTS	Aug 04, 2005	Substantially Equivalent	Collagen Matrix, Inc.
K033815	BIO-OSS, BIO-OSS BLOCKS AND BIO-OSS COLLAGEN	Jan 15, 2004	Substantially Equivalent	Geistlich-Pharma