Bone Grafting Material, Synthetic
Regulation 872.3930
3510(k)s in 12 months (231 all time)
0recalls in 12 months (14 all time)
13recalls that name a 510(k)
Top companies in LYC
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 6, 2026 | K253317 | Cytrans Elashield GC America, Inc. | LYC |
| May 14, 2026 | K253883 | Bonalive Maxillofacial Bonalive , Ltd., FI | LYC |
| Mar 6, 2026 | K251818 | BONTREE PLUS Hudens Bio Co., Ltd., KR | LYC |
| Sep 17, 2025 | K244006 | FG Bone Graft M Full Golden Biotech Co., Ltd., TW | LYC |
| Aug 29, 2025 | K243745 | FG Bone Graft B Full Golden Biotech Corporation, TW | LYC |
| Feb 21, 2025 | K241186 | Synthetic Bone Graft Particulate Shenzhen Dazhou Medical Technology Co., Ltd., CN | LYC |
| Dec 30, 2022 | K213260 | CMFlexTM Dimension Inx Corp. | LYC |
| Mar 4, 2022 | K202675 | InRoad® Dental Synthetic Bone Graft Osteogene Tech Corp | LYC |
| Oct 2, 2020 | K201546 | OsOpia Synthetic Bone Void Filler Revisios BV, NL | LYC |
| Sep 24, 2020 | K201051 | Straumann BoneCeramic Institut Straumann AG, CH | LYC |
| Aug 17, 2020 | K192597 | Cytrans Granules GC America, Inc. | LYC |
| Sep 14, 2016 | K153676 | OSTEON III Genoss Co., Ltd., KR | LYC |
| Jul 14, 2016 | K153230 | ShefaBone SCPC Resorbable Bone Graft The Implantech Inc./Shefabone | LYC |
| Jun 10, 2014 | K140374 | MASTERGRAFT PUTTY Medtronic Sofamor Danek USA, Inc. | LYC |
| Dec 5, 2013 | K121177 | BOND APATITE Augma Biomaterials, Ltd. | LYC |
| Sep 27, 2013 | K131385 | EASY-GRAFT Degradable Solutions AG | LYC |
| Dec 20, 2012 | K111105 | CURASAN OSSEOLIVE DENTAL Curasan AG, IT | LYC |
| Sep 20, 2012 | K113282 | CERASORB DENTAL,CERADORB M DENTAL, CERASORB PERIO Riemser Arzeimittel AG | LYC |
| Aug 21, 2012 | K122240 | BONE PLUS BCP EAGLE EYE Megagen Implant Co., Ltd. | LYC |
| Jan 27, 2012 | K113049 | SOCKET GRAFT Steiner Laboratories | LYC |
| Jan 17, 2012 | K112716 | OSTEON II Genoss Co., Ltd., KR | LYC |
| Dec 22, 2011 | K110198 | BLUE SKY BIO TCP Blue Sky Bio, LLC | LYC |
| Dec 16, 2011 | K112428 | NOVABONE DENTAL MORSELS - BIOACTIVE SYNTHETIC BONE GRAFT Novabone Products, LLC | LYC |
| Nov 29, 2011 | K111087 | FOUNDATION Olympus Terumo Biomaterials Corporation | LYC |
| Nov 3, 2011 | K103820 | REPROBONE DENTAL GRAFTING MATERIAL Ceramisys, Ltd. | LYC |
| May 13, 2011 | K110449 | ENDOBON XENOGRAFT GRANULES Biomet 3i | LYC |
| May 6, 2011 | K102208 | NANOGEN Orthogen, LLC | LYC |
| Apr 20, 2011 | K101827 | OSTEOSCAF Texas Innovative Medical Devices (Dba) Skeletal | LYC |
| Mar 10, 2011 | K103709 | CERACELL DENTAL Curasan AG, IT | LYC |
| Jan 12, 2011 | K102872 | OSBONE DENTAL Curasan AG | LYC |
| Dec 21, 2010 | K100883 | CARRIGEN Etex Corp. | LYC |
| Dec 3, 2010 | K102812 | GAMMA-BSM; BETA-BSM; EQUIVABONE Etex Corporation | LYC |
| Nov 19, 2010 | K102015 | OSTEON, OSTEON SINUS, OSTEON LIFTING Genoss Co., Ltd. | LYC |
| Oct 26, 2010 | K101718 | OSSEOCONDUCT Steiner Laboratories Div of Steiner Healthcare, LLC | LYC |
| Oct 21, 2010 | K101014 | BOND BONE Mis Implants Technologies , Ltd., IL | LYC |
| Sep 27, 2010 | K091618 | VITOMATRIX Orthovita, Inc. | LYC |
| Sep 15, 2010 | K101426 | CEROS TCP GRANULES Mathys, Ltd. | LYC |
| Jul 2, 2010 | K090950 | BONE PLUS BCP Megagen Implant Co., Ltd. | LYC |
| Jun 16, 2010 | K092194 | POLYBONE DENTAL Kyung Won Medical Co., Ltd. | LYC |
| May 25, 2010 | K093390 | HEALOS DENTAL BONE GRAFT SUBSTITUTE (ALSO CALLED HEALOS OR HEALOS II) MODEL 6008, 6025 Depuy Spine, Inc. | LYC |
| Apr 22, 2010 | K093871 | PERIOPHIL B-TCP Cytophil, Inc. | LYC |
| Mar 30, 2010 | K100671 | NOVABONE DENTAL PUTTY-BIOACTIVE SYNTHETIC BONE GRAFT Novabone Products, LLC | LYC |
| Mar 15, 2010 | K093122 | MBCP+ Biomatlante, FR | LYC |
| Dec 30, 2009 | K092087 | MEDTRONIC DENTAL TCP Medtronic Sofamor Danek USA, Inc. | LYC |
| Dec 23, 2009 | K091729 | ALPHA-BSM, BETA-BSM, GAMMA-BSM, EQUIVABONE Etex Corp. | LYC |
| Dec 18, 2009 | K092788 | PERIOPHIL BIPHASIC Cytophil, Inc. | LYC |
| Dec 8, 2009 | K083372 | ARROWBONE-A, ARROWBONE-B Brainbase Corporation | LYC |
| Nov 25, 2009 | K092567 | MODIFICATION TO UNIGRAFT Unicare Biomedical, Inc. | LYC |
| Jul 30, 2009 | K090850 | ACTIFUSE BONE GRAFT SUBSTITUTE, ACTIFUSE MICROGRANULES BONE GRAFT SUBSTITUTE Apatech , Ltd. | LYC |
| Jun 15, 2009 | K091484 | NOVABONE DENTAL PUTTY - BIOACTIVE SYNTHETIC BONE GRAFT Novabone Products, LLC | LYC |
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