Atlas FDA

NPM

40 FDA 510(k) clearances · Product code

208 daysmedian time to decision
462 days90th percentile
40clearances measured

FDA profile

Official device name
Bone Grafting Material, Animal Source
Device class
Class II (moderate risk)
Regulation
21 CFR 872.3930
Medical specialty
Dental
Flags
Implant
FDA 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.
Adverse events (MAUDE)
2022: 27 · 2026: 26
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
BOSS (K253723)Medpark Co., Ltd.2026-06-16
Geistlich Bio-Oss®; Geistlich Bio-Oss Pen® (K251786)Geistlich Pharma AG2025-07-11
SwissGraft X (K251613)Geistlich Pharma AG2025-06-26
Geistlich Bio-Flow® (K242510)Geistlich Pharma AG2025-03-07
Xenograft Bovine Bone Particulate (K240133)Collagen Solutions, LLC2024-08-16
THE Graft Collagen (K230305)Purgo Biologics, Inc.2024-07-24
Geistlich Bio-Oss® (K240661)Geistlich Pharma AG2024-07-12
S1 (K231672)Medpark Co., Ltd.2023-10-13
InterOss Collagen (K221808)Sigmagraft, Inc.2023-03-18
Wishbone HA (K211551)Wishbone SA2021-08-20
Porcine Mineral Collagen Composite (K202183)Collagen Matrix, Inc.2021-04-02
Porcine Mineral Collagen Composite Moldable (K201859)Collagen Matrix, Inc.2020-09-11
DSM Biomedical Dental Bone Graft Plus (K193212)Dsm Biomedical2020-09-10
The Graft Bone Substitute (K191737)Purgo Biologics, Inc.2020-02-14
Straumann cerabone (K173594)Institut Straumann AG2018-10-19
The Graft Natural Bone Substitute (K173188)Purgo Biologics, Inc.2018-07-20
Anorganic Bone Mineral with Collagen in Delivery Applicator (K171008)Collagen Matrix, Inc.2017-10-30
OSSIX BONE (K163714)Datum Dental, Ltd.2017-07-18
Anorganic Bone Mineral in Delivery Applicator (K170541)Collagen Matrix, Inc.2017-07-07
DSM Biomedical Dental Bone Graft (K170245)Kensey Nash Corporation Dba Dsm Biomedical2017-05-16
Porcine Anorganic Bone Mineral in Delivery Applicator (K162158)Collagen Matrix, Inc.2017-02-09
A-Oss (K151542)Hiossen, Inc.2016-08-03
Regenomer® Syringe, Regenomer® Plug, Regenomer® Block (K150079)Nibec Co., Ltd.2015-12-10
InterOss (K151209)Sigmagraft, Inc.2015-11-06
OCS-B COLLAGEN (K142040)Nibec Co., Ltd.2015-07-31
TI-OSS (K140021)Chiyewon2015-06-05
PORCINE ANORGANIC BONE MINERAL (K140714)Collagen Matrix, Inc.2014-07-16
SYNERGY (K123876)Odontit S.A.2014-05-22
GEISTLICH BIO-OSS, GEISTLICH BIO-OSS COLLAGEN, GEISTLICH COMBI-KIT COLLAGEN, GEISTLICH PERIO SYSTEM COMBI PACK, GEISTLIC (K122894)Geistlich Pharma AG2013-02-15
OCS-B (K113246)Nibec Company, Limited2013-01-16
CERASORB PLUS (K120152)Riemser Arzneimittel AG2012-08-13
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 (K120601)Geistlich Pharma AG2012-05-24
GEISTLICH COMBI-KIT COLLEGEN (K112572)Geistlich Pharma AG2011-12-28
GEISTLICH PERIO-SYSTEM COMBI-PACK , GEISTLICH BIO-GIDE PERIO (K112575)Geistlich Pharma AG2011-12-27
EQUIMATRIX (K111816)Luitpold Pharmaceuticals, Inc.2011-09-29
OSTA MAXIGRO AND REGIGRO (K091424)Osta Technologies2010-08-18
BIO-OSS COLLAGEN (K092428)Ed. Geistlich Soehne AG Fuer Chemische Industrie2010-03-18
OSTEOTAPE (K090794)Impladent , Ltd.2009-12-10
OSTEOGUIDE ANORGANIC BONE MINERAL PRODUCTS (K043034)Collagen Matrix, Inc.2005-08-04
BIO-OSS, BIO-OSS BLOCKS AND BIO-OSS COLLAGEN (K033815)Geistlich-Pharma2004-01-15

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