Atlas FDA

LYC

231 FDA 510(k) clearances · Product code

104 daysmedian time to decision
332 days90th percentile
231clearances measured

FDA profile

Official device name
Bone Grafting Material, Synthetic
Device class
Class II (moderate risk)
Regulation
21 CFR 872.3930
Medical specialty
Dental
Flags
Implant
FDA definition
A synthetic bone grafting material is synthetically-derived device, such as hydroxylapatite, intended to fill, augment, or reconstruct periodontal and or bony defects of the upper or lower jaw.
Adverse events (MAUDE)
2014: 9 · 2015: 14 · 2016: 140 · 2017: 19 · 2018: 14 · 2019: 15
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
Cytrans™ Elashield (K253317)GC America, Inc.2026-07-06
Bonalive Maxillofacial (K253883)Bonalive , Ltd.2026-05-14
BONTREE PLUS (K251818)Hudens Bio Co., Ltd.2026-03-06
FG Bone Graft M (K244006)Full Golden Biotech Co., Ltd.2025-09-17
FG Bone Graft B (K243745)Full Golden Biotech Corporation2025-08-29
Synthetic Bone Graft Particulate (K241186)Shenzhen Dazhou Medical Technology Co., Ltd.2025-02-21
CMFlexTM (K213260)Dimension Inx Corp.2022-12-30
InRoad® Dental Synthetic Bone Graft (K202675)Osteogene Tech Corp2022-03-04
OsOpia Synthetic Bone Void Filler (K201546)Revisios BV2020-10-02
Straumann BoneCeramic (K201051)Institut Straumann AG2020-09-24
Cytrans Granules (K192597)GC America, Inc.2020-08-17
OSTEON III (K153676)Genoss Co., Ltd.2016-09-14
ShefaBone SCPC Resorbable Bone Graft (K153230)The Implantech Inc./Shefabone2016-07-14
MASTERGRAFT PUTTY (K140374)Medtronic Sofamor Danek USA, Inc.2014-06-10
BOND APATITE (K121177)Augma Biomaterials, Ltd.2013-12-05
EASY-GRAFT (K131385)Degradable Solutions AG2013-09-27
CURASAN OSSEOLIVE DENTAL (K111105)Curasan AG2012-12-20
CERASORB DENTAL,CERADORB M DENTAL, CERASORB PERIO (K113282)Riemser Arzeimittel AG2012-09-20
BONE PLUS BCP EAGLE EYE (K122240)Megagen Implant Co., Ltd.2012-08-21
SOCKET GRAFT (K113049)Steiner Laboratories2012-01-27
OSTEON II (K112716)Genoss Co., Ltd.2012-01-17
BLUE SKY BIO TCP (K110198)Blue Sky Bio, LLC2011-12-22
NOVABONE DENTAL MORSELS - BIOACTIVE SYNTHETIC BONE GRAFT (K112428)Novabone Products, LLC2011-12-16
FOUNDATION (K111087)Olympus Terumo Biomaterials Corporation2011-11-29
REPROBONE DENTAL GRAFTING MATERIAL (K103820)Ceramisys, Ltd.2011-11-03
ENDOBON XENOGRAFT GRANULES (K110449)Biomet 3i2011-05-13
NANOGEN (K102208)Orthogen, LLC2011-05-06
OSTEOSCAF (K101827)Texas Innovative Medical Devices (Dba) Skeletal2011-04-20
CERACELL DENTAL (K103709)Curasan AG2011-03-10
OSBONE DENTAL (K102872)Curasan AG2011-01-12
CARRIGEN (K100883)Etex Corp.2010-12-21
GAMMA-BSM; BETA-BSM; EQUIVABONE (K102812)Etex Corporation2010-12-03
OSTEON, OSTEON SINUS, OSTEON LIFTING (K102015)Genoss Co., Ltd.2010-11-19
OSSEOCONDUCT (K101718)Steiner Laboratories Div of Steiner Healthcare, LLC2010-10-26
BOND BONE (K101014)Mis Implants Technologies , Ltd.2010-10-21
VITOMATRIX (K091618)Orthovita, Inc.2010-09-27
CEROS TCP GRANULES (K101426)Mathys, Ltd.2010-09-15
BONE PLUS BCP (K090950)Megagen Implant Co., Ltd.2010-07-02
POLYBONE DENTAL (K092194)Kyung Won Medical Co., Ltd.2010-06-16
HEALOS DENTAL BONE GRAFT SUBSTITUTE (ALSO CALLED HEALOS OR HEALOS II) MODEL 6008, 6025 (K093390)Depuy Spine, Inc.2010-05-25
PERIOPHIL B-TCP (K093871)Cytophil, Inc.2010-04-22
NOVABONE DENTAL PUTTY-BIOACTIVE SYNTHETIC BONE GRAFT (K100671)Novabone Products, LLC2010-03-30
MBCP+ (K093122)Biomatlante2010-03-15
MEDTRONIC DENTAL TCP (K092087)Medtronic Sofamor Danek USA, Inc.2009-12-30
ALPHA-BSM, BETA-BSM, GAMMA-BSM, EQUIVABONE (K091729)Etex Corp.2009-12-23
PERIOPHIL BIPHASIC (K092788)Cytophil, Inc.2009-12-18
ARROWBONE-A, ARROWBONE-B (K083372)Brainbase Corporation2009-12-08
MODIFICATION TO UNIGRAFT (K092567)Unicare Biomedical, Inc.2009-11-25
ACTIFUSE BONE GRAFT SUBSTITUTE, ACTIFUSE MICROGRANULES BONE GRAFT SUBSTITUTE (K090850)Apatech , Ltd.2009-07-30
NOVABONE DENTAL PUTTY - BIOACTIVE SYNTHETIC BONE GRAFT (K091484)Novabone Products, LLC2009-06-15
BONGROS HA (K090793)Bioalpha, Inc.2009-05-19
CYTOFLEX RESORB, MODEL C03-0010 THROUGH C03-090 (K090083)Unicare Biomedical, Inc.2009-03-23
BOND BONE (K083858)Augma Biomaterials, Ltd.2009-03-17
NANGEL (K083005)Teknimed, S.A.2009-03-04
BIOACTYS (K082286)Graftys2009-02-24
SYNOSS COLLAGEN SYNTHETIC MINERAL-COLLAGEN BONE GRAFT MATRIX (K083742)Collagen Matrix, Inc.2009-02-12
MASTERGRAFT RESORBABLE CERAMIC GRANULES (K082917)Medtronic Sofamor Danek2009-01-09
MASTERGRAFT PUTTY (K081784)Medtronic Sofamor Danek2008-09-17
FORTOSS VITAL (K082383)Biocomposites, Ltd.2008-09-05
HEALOS II BONE GRAFT SUBSTITUTE (K081432)Depuy Spine, Inc.2008-08-29
TRICOS A RESORBABLE SUBSTITUTE (K081721)Baxter Healthcare Corp2008-08-06
OSFERION D (K081561)Olympus Terumo Biomaterials Corporation2008-07-28
BONEMEDIK-DM (K080772)Meta Biomed Co., Ltd.2008-06-03
BIO-SCAFFOLD BIOSCAFF ALVELAC RESOBABLE SCAFFOLD (K080308)Bioscaffold International Pte, Ltd.2008-04-14
TRICOS T RESORBABLE BONE SUBSTITUTE (K073571)Baxter Healthcare Corporation2008-04-08
SYNOSS SYNTHETIC BONE GRAFT MATERIAL (K072397)Collagen Matrix, Inc.2007-10-18
OSTEOGRAF/N-300 (K071817)Dentsply Interntional2007-09-04
OSTEOGRAF/D-300 (K072052)Dentsply International, Inc.2007-08-08
OSTEOGRAF/D-700 (K072056)Dentsply International, Inc.2007-08-06
OSTEOGRAF/LD-300 (K072057)Dentsply International, Inc.2007-08-06
MODIFICATION TO: OSTEOGRAF/N-700 (K072058)Dentsply Interntional2007-08-03
INION BIORESTORE (K070784)Inion OY2007-07-24
BONALIVE GRANULES AND BONALIVE PLATES (K070055)Vivoxid , Ltd.2007-06-25
RTR SYRINGE (K063634)Septodont2007-05-11
OSTEON, MODELS GBG0305, GBG0510, GBG1020, GBG2030, GBG3040, GBG4050 (K062834)Genoss Co., Ltd.2007-04-24
ODONCER (K062102)Teknimed, S.A.2007-04-16
PERIOGLAS PUTTY-BIOACTIVE BONE GRAFT GEL (K063596)Novabone Products, LLC2007-02-22
NOVABONE DENTAL PUTTY-BIOACTIVE SYNTHETIC BONE GRAFT (K063549)Novabone Products, LLC2007-02-12
REGEN BIOCEMENT (K063010)Steiner Laboratories2006-11-28
SOCKET GRAFT (K052493)Steiner Laboratories2006-06-09
MBCP GEL (K060732)Biomatlante2006-06-02
BONEGEN - TR (K060285)Bio-Lok Intl., Inc.2006-03-16
OSSAPLAST DENTAL (PARTICLE SIZE OF 500 TO 1000 UM TO 2000 UM) (K053374)Ossacur AG2006-02-21
PERIOGLAS BONE GRAFT PARTICULATE (K053387)Novabone Products, LLC2006-02-14
SYNTHES (USA) CHRONOS-BETA-TCP (K053022)Synthes (Usa)2006-01-23
MBCP (K051885)Biomatlante2005-09-16
SYNTHOGRAFT (K051091)Bicon, Inc.2005-09-01
FORTOSS VITAL BONE GRAFT SUBSTITUTE (K050170)Biocomposites, Ltd.2005-08-26
BIOPLANT (K050984)Kerr Dental Materials Center2005-08-11
CERASORB DENTAL, CERASORB M DENTAL AND CERASORB PERIO (K051443)Curasan Ag, Frankfurt Facility2005-07-22
CALC-I-OSS (K042583)Ultradent Products, Inc.2005-07-19
ACE SURGICALPLASTER CALCIUM SULFACE HEMIHYDRATE (K051381)Ace Surgical Supply Co., Inc.2005-07-15
BIORESORB MACRO PORE (K050260)Oraltronics Dental Implant Technology GmbH2005-07-15
CALFORMA CALCIUM SULFATE BONE GRAFT BARRIER, MODEL 0.5G/1.0G (K042730)Lifecorebiomedical2005-02-14
OSTIM (K030052)Heraeus Kulzer, Inc.2004-12-06
OSSATURA DENTAL (K042706)Isotis Orthobiologics, Inc.2004-10-20
FOUNDATION (K040783)Terumo Corp.2004-10-13
OSSATURA DENTAL (K031813)Isotis NV2004-08-20
CALMATRIX CALCIUM SULFATE BONE GRAFT BINDER (K041324)Lifecore Biomedical, Inc.2004-07-19
BBP BONE SUBSTITUTES (K030195)Oct, USA, Inc.2004-06-17
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