Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

NPM — Predicate Candidate Screening

40 FDA 510(k) clearances under this product code; the 50 most recent screened below.

208 daysmedian FDA review time

462 days90th percentile

40clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K253723	BOSS	Medpark Co., Ltd.	2026-06-16	204	0
K251786	Geistlich Bio-Oss®; Geistlich Bio-Oss Pen®	Geistlich Pharma AG	2025-07-11	30	0
K251613	SwissGraft X	Geistlich Pharma AG	2025-06-26	30	0
K242510	Geistlich Bio-Flow®	Geistlich Pharma AG	2025-03-07	196	0
K240133	Xenograft Bovine Bone Particulate	Collagen Solutions, LLC	2024-08-16	211	0
K230305	THE Graft Collagen	Purgo Biologics, Inc.	2024-07-24	537	0
K240661	Geistlich Bio-Oss®	Geistlich Pharma AG	2024-07-12	126	0
K231672	S1	Medpark Co., Ltd.	2023-10-13	127	0
K221808	InterOss Collagen	Sigmagraft, Inc.	2023-03-18	269	0
K211551	Wishbone HA	Wishbone SA	2021-08-20	93	0
K202183	Porcine Mineral Collagen Composite	Collagen Matrix, Inc.	2021-04-02	241	0
K201859	Porcine Mineral Collagen Composite Moldable	Collagen Matrix, Inc.	2020-09-11	67	0
K193212	DSM Biomedical Dental Bone Graft Plus	Dsm Biomedical	2020-09-10	294	0
K191737	The Graft Bone Substitute	Purgo Biologics, Inc.	2020-02-14	231	0
K173594	Straumann cerabone	Institut Straumann AG	2018-10-19	332	0
K173188	The Graft Natural Bone Substitute	Purgo Biologics, Inc.	2018-07-20	291	0
K171008	Anorganic Bone Mineral with Collagen in Delivery Applicator	Collagen Matrix, Inc.	2017-10-30	209	0
K163714	OSSIX BONE	Datum Dental, Ltd.	2017-07-18	200	0
K170541	Anorganic Bone Mineral in Delivery Applicator	Collagen Matrix, Inc.	2017-07-07	134	0
K170245	DSM Biomedical Dental Bone Graft	Kensey Nash Corporation Dba Dsm Biomedical	2017-05-16	110	0
K162158	Porcine Anorganic Bone Mineral in Delivery Applicator	Collagen Matrix, Inc.	2017-02-09	191	0
K151542	A-Oss	Hiossen, Inc.	2016-08-03	422	0
K150079	Regenomer® Syringe, Regenomer® Plug, Regenomer® Block	Nibec Co., Ltd.	2015-12-10	329	0
K151209	InterOss	Sigmagraft, Inc.	2015-11-06	184	0
K142040	OCS-B COLLAGEN	Nibec Co., Ltd.	2015-07-31	368	0
K140021	TI-OSS	Chiyewon	2015-06-05	518	0
K140714	PORCINE ANORGANIC BONE MINERAL	Collagen Matrix, Inc.	2014-07-16	117	0
K123876	SYNERGY	Odontit S.A.	2014-05-22	521	0
K122894	GEISTLICH BIO-OSS, GEISTLICH BIO-OSS COLLAGEN, GEISTLICH COM	Geistlich Pharma AG	2013-02-15	148	0
K113246	OCS-B	Nibec Company, Limited	2013-01-16	441	0
K120152	CERASORB PLUS	Riemser Arzneimittel AG	2012-08-13	208	0
K120601	GEISTLICH BIO-OSS PEN (0.25 G, 0.25-1.0MM GRANULES), GEISTLI	Geistlich Pharma AG	2012-05-24	86	3
K112572	GEISTLICH COMBI-KIT COLLEGEN	Geistlich Pharma AG	2011-12-28	113	0
K112575	GEISTLICH PERIO-SYSTEM COMBI-PACK , GEISTLICH BIO-GIDE PERIO	Geistlich Pharma AG	2011-12-27	112	0
K111816	EQUIMATRIX	Luitpold Pharmaceuticals, Inc.	2011-09-29	94	0
K091424	OSTA MAXIGRO AND REGIGRO	Osta Technologies	2010-08-18	462	0
K092428	BIO-OSS COLLAGEN	Ed. Geistlich Soehne AG Fuer Chemische Industrie	2010-03-18	223	0
K090794	OSTEOTAPE	Impladent , Ltd.	2009-12-10	261	0
K043034	OSTEOGUIDE ANORGANIC BONE MINERAL PRODUCTS	Collagen Matrix, Inc.	2005-08-04	274	1
K033815	BIO-OSS, BIO-OSS BLOCKS AND BIO-OSS COLLAGEN	Geistlich-Pharma	2004-01-15	37	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