FDA Product Code
FDA Product Code LYC — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Dental
- 21 CFR Citation
- 872.3930
510(k) Clearances — 231 records · page 1 of 3
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K253317 | Cytrans Elashield | GC America, Inc. | 2026-07-06 | Traditional | PDF ↗ |
| K253883 | Bonalive Maxillofacial | Bonalive , Ltd. | 2026-05-14 | Special | PDF ↗ |
| K251818 | BONTREE PLUS | Hudens Bio Co., Ltd. | 2026-03-06 | Traditional | PDF ↗ |
| K244006 | FG Bone Graft M | Full Golden Biotech Co., Ltd. | 2025-09-17 | Traditional | PDF ↗ |
| K243745 | FG Bone Graft B | Full Golden Biotech Corporation | 2025-08-29 | Traditional | PDF ↗ |
| K241186 | Synthetic Bone Graft Particulate | Shenzhen Dazhou Medical Technology Co., Ltd. | 2025-02-21 | Traditional | PDF ↗ |
| K213260 | CMFlexTM | Dimension Inx Corp. | 2022-12-30 | Traditional | PDF ↗ |
| K202675 | InRoad® Dental Synthetic Bone Graft | Osteogene Tech Corp | 2022-03-04 | Traditional | PDF ↗ |
| K201546 | OsOpia Synthetic Bone Void Filler | Revisios BV | 2020-10-02 | Traditional | PDF ↗ |
| K201051 | Straumann BoneCeramic | Institut Straumann AG | 2020-09-24 | Traditional | PDF ↗ |
| K192597 | Cytrans Granules | GC America, Inc. | 2020-08-17 | Abbreviated | PDF ↗ |
| K153676 | OSTEON III | Genoss Co., Ltd. | 2016-09-14 | Traditional | PDF ↗ |
| K153230 | ShefaBone SCPC Resorbable Bone Graft | The Implantech Inc./Shefabone | 2016-07-14 | Traditional | PDF ↗ |
| K140374 | MASTERGRAFT PUTTY | Medtronic Sofamor Danek USA, Inc. | 2014-06-10 | Traditional | PDF ↗ |
| K121177 | BOND APATITE | Augma Biomaterials, Ltd. | 2013-12-05 | Traditional | PDF ↗ |
| K131385 | EASY-GRAFT | Degradable Solutions AG | 2013-09-27 | Traditional | PDF ↗ |
| K111105 | CURASAN OSSEOLIVE DENTAL | Curasan AG | 2012-12-20 | Abbreviated | PDF ↗ |
| K113282 | CERASORB DENTAL,CERADORB M DENTAL, CERASORB PERIO | Riemser Arzeimittel AG | 2012-09-20 | Special | PDF ↗ |
| K122240 | BONE PLUS BCP EAGLE EYE | Megagen Implant Co., Ltd. | 2012-08-21 | Special | PDF ↗ |
| K113049 | SOCKET GRAFT | Steiner Laboratories | 2012-01-27 | Traditional | PDF ↗ |
| K112716 | OSTEON II | Genoss Co., Ltd. | 2012-01-17 | Traditional | PDF ↗ |
| K110198 | BLUE SKY BIO TCP | Blue Sky Bio, LLC | 2011-12-22 | Traditional | PDF ↗ |
| K112428 | NOVABONE DENTAL MORSELS - BIOACTIVE SYNTHETIC BONE GRAFT | Novabone Products, LLC | 2011-12-16 | Traditional | PDF ↗ |
| K111087 | FOUNDATION | Olympus Terumo Biomaterials Corporation | 2011-11-29 | Traditional | PDF ↗ |
| K103820 | REPROBONE DENTAL GRAFTING MATERIAL | Ceramisys, Ltd. | 2011-11-03 | Traditional | PDF ↗ |
| K110449 | ENDOBON XENOGRAFT GRANULES | Biomet 3i | 2011-05-13 | Traditional | PDF ↗ |
| K102208 | NANOGEN | Orthogen, LLC | 2011-05-06 | Traditional | PDF ↗ |
| K101827 | OSTEOSCAF | Texas Innovative Medical Devices (Dba) Skeletal | 2011-04-20 | Traditional | PDF ↗ |
| K103709 | CERACELL DENTAL | Curasan AG | 2011-03-10 | Abbreviated | PDF ↗ |
| K102872 | OSBONE DENTAL | Curasan AG | 2011-01-12 | Traditional | PDF ↗ |
| K100883 | CARRIGEN | Etex Corp. | 2010-12-21 | Traditional | PDF ↗ |
| K102812 | GAMMA-BSM; BETA-BSM; EQUIVABONE | Etex Corporation | 2010-12-03 | Special | PDF ↗ |
| K102015 | OSTEON, OSTEON SINUS, OSTEON LIFTING | Genoss Co., Ltd. | 2010-11-19 | Special | PDF ↗ |
| K101718 | OSSEOCONDUCT | Steiner Laboratories Div of Steiner Healthcare, LLC | 2010-10-26 | Traditional | PDF ↗ |
| K101014 | BOND BONE | Mis Implants Technologies , Ltd. | 2010-10-21 | Traditional | PDF ↗ |
| K091618 | VITOMATRIX | Orthovita, Inc. | 2010-09-27 | Traditional | PDF ↗ |
| K101426 | CEROS TCP GRANULES | Mathys, Ltd. | 2010-09-15 | Traditional | PDF ↗ |
| K090950 | BONE PLUS BCP | Megagen Implant Co., Ltd. | 2010-07-02 | Traditional | PDF ↗ |
| K092194 | POLYBONE DENTAL | Kyung Won Medical Co., Ltd. | 2010-06-16 | Traditional | PDF ↗ |
| K093390 | HEALOS DENTAL BONE GRAFT SUBSTITUTE (ALSO CALLED HEALOS OR HEALOS II) MODEL 6008, 6025 | Depuy Spine, Inc. | 2010-05-25 | Special | PDF ↗ |
| K093871 | PERIOPHIL B-TCP | Cytophil, Inc. | 2010-04-22 | Traditional | PDF ↗ |
| K100671 | NOVABONE DENTAL PUTTY-BIOACTIVE SYNTHETIC BONE GRAFT | Novabone Products, LLC | 2010-03-30 | Special | PDF ↗ |
| K093122 | MBCP+ | Biomatlante | 2010-03-15 | Traditional | PDF ↗ |
| K092087 | MEDTRONIC DENTAL TCP | Medtronic Sofamor Danek USA, Inc. | 2009-12-30 | Traditional | PDF ↗ |
| K091729 | ALPHA-BSM, BETA-BSM, GAMMA-BSM, EQUIVABONE | Etex Corp. | 2009-12-23 | Traditional | PDF ↗ |
| K092788 | PERIOPHIL BIPHASIC | Cytophil, Inc. | 2009-12-18 | Traditional | PDF ↗ |
| K083372 | ARROWBONE-A, ARROWBONE-B | Brainbase Corporation | 2009-12-08 | Traditional | PDF ↗ |
| K092567 | MODIFICATION TO UNIGRAFT | Unicare Biomedical, Inc. | 2009-11-25 | Traditional | PDF ↗ |
| K090850 | ACTIFUSE BONE GRAFT SUBSTITUTE, ACTIFUSE MICROGRANULES BONE GRAFT SUBSTITUTE | Apatech , Ltd. | 2009-07-30 | Traditional | PDF ↗ |
| K091484 | NOVABONE DENTAL PUTTY - BIOACTIVE SYNTHETIC BONE GRAFT | Novabone Products, LLC | 2009-06-15 | Special | PDF ↗ |
| K090793 | BONGROS HA | Bioalpha, Inc. | 2009-05-19 | Traditional | PDF ↗ |
| K090083 | CYTOFLEX RESORB, MODEL C03-0010 THROUGH C03-090 | Unicare Biomedical, Inc. | 2009-03-23 | Traditional | PDF ↗ |
| K083858 | BOND BONE | Augma Biomaterials, Ltd. | 2009-03-17 | Traditional | PDF ↗ |
| K083005 | NANGEL | Teknimed, S.A. | 2009-03-04 | Traditional | PDF ↗ |
| K082286 | BIOACTYS | Graftys | 2009-02-24 | Abbreviated | PDF ↗ |
| K083742 | SYNOSS COLLAGEN SYNTHETIC MINERAL-COLLAGEN BONE GRAFT MATRIX | Collagen Matrix, Inc. | 2009-02-12 | Traditional | PDF ↗ |
| K082917 | MASTERGRAFT RESORBABLE CERAMIC GRANULES | Medtronic Sofamor Danek | 2009-01-09 | Traditional | PDF ↗ |
| K081784 | MASTERGRAFT PUTTY | Medtronic Sofamor Danek | 2008-09-17 | Traditional | PDF ↗ |
| K082383 | FORTOSS VITAL | Biocomposites, Ltd. | 2008-09-05 | Special | PDF ↗ |
| K081432 | HEALOS II BONE GRAFT SUBSTITUTE | Depuy Spine, Inc. | 2008-08-29 | Traditional | PDF ↗ |
| K081721 | TRICOS A RESORBABLE SUBSTITUTE | Baxter Healthcare Corp | 2008-08-06 | Traditional | PDF ↗ |
| K081561 | OSFERION D | Olympus Terumo Biomaterials Corporation | 2008-07-28 | Traditional | PDF ↗ |
| K080772 | BONEMEDIK-DM | Meta Biomed Co., Ltd. | 2008-06-03 | Traditional | PDF ↗ |
| K080308 | BIO-SCAFFOLD BIOSCAFF ALVELAC RESOBABLE SCAFFOLD | Bioscaffold International Pte, Ltd. | 2008-04-14 | Abbreviated | PDF ↗ |
| K073571 | TRICOS T RESORBABLE BONE SUBSTITUTE | Baxter Healthcare Corporation | 2008-04-08 | Abbreviated | PDF ↗ |
| K072397 | SYNOSS SYNTHETIC BONE GRAFT MATERIAL | Collagen Matrix, Inc. | 2007-10-18 | Traditional | PDF ↗ |
| K071817 | OSTEOGRAF/N-300 | Dentsply Interntional | 2007-09-04 | Special | PDF ↗ |
| K072052 | OSTEOGRAF/D-300 | Dentsply International, Inc. | 2007-08-08 | Special | PDF ↗ |
| K072057 | OSTEOGRAF/LD-300 | Dentsply International, Inc. | 2007-08-06 | Special | PDF ↗ |
| K072056 | OSTEOGRAF/D-700 | Dentsply International, Inc. | 2007-08-06 | Special | PDF ↗ |
| K072058 | MODIFICATION TO: OSTEOGRAF/N-700 | Dentsply Interntional | 2007-08-03 | Special | PDF ↗ |
| K070784 | INION BIORESTORE | Inion OY | 2007-07-24 | Traditional | PDF ↗ |
| K070055 | BONALIVE GRANULES AND BONALIVE PLATES | Vivoxid , Ltd. | 2007-06-25 | Traditional | PDF ↗ |
| K063634 | RTR SYRINGE | Septodont | 2007-05-11 | Abbreviated | PDF ↗ |
| K062834 | OSTEON, MODELS GBG0305, GBG0510, GBG1020, GBG2030, GBG3040, GBG4050 | Genoss Co., Ltd. | 2007-04-24 | Abbreviated | PDF ↗ |
| K062102 | ODONCER | Teknimed, S.A. | 2007-04-16 | Traditional | PDF ↗ |
| K063596 | PERIOGLAS PUTTY-BIOACTIVE BONE GRAFT GEL | Novabone Products, LLC | 2007-02-22 | Traditional | PDF ↗ |
| K063549 | NOVABONE DENTAL PUTTY-BIOACTIVE SYNTHETIC BONE GRAFT | Novabone Products, LLC | 2007-02-12 | Traditional | PDF ↗ |
| K063010 | REGEN BIOCEMENT | Steiner Laboratories | 2006-11-28 | Traditional | PDF ↗ |
| K052493 | SOCKET GRAFT | Steiner Laboratories | 2006-06-09 | Traditional | PDF ↗ |
| K060732 | MBCP GEL | Biomatlante | 2006-06-02 | Traditional | PDF ↗ |
| K060285 | BONEGEN - TR | Bio-Lok Intl., Inc. | 2006-03-16 | Traditional | PDF ↗ |
| K053374 | OSSAPLAST DENTAL (PARTICLE SIZE OF 500 TO 1000 UM TO 2000 UM) | Ossacur AG | 2006-02-21 | Abbreviated | PDF ↗ |
| K053387 | PERIOGLAS BONE GRAFT PARTICULATE | Novabone Products, LLC | 2006-02-14 | Traditional | PDF ↗ |
| K053022 | SYNTHES (USA) CHRONOS-BETA-TCP | Synthes (Usa) | 2006-01-23 | Traditional | PDF ↗ |
| K051885 | MBCP | Biomatlante | 2005-09-16 | Traditional | PDF ↗ |
| K051091 | SYNTHOGRAFT | Bicon, Inc. | 2005-09-01 | Traditional | PDF ↗ |
| K050170 | FORTOSS VITAL BONE GRAFT SUBSTITUTE | Biocomposites, Ltd. | 2005-08-26 | Traditional | PDF ↗ |
| K050984 | BIOPLANT | Kerr Dental Materials Center | 2005-08-11 | Traditional | PDF ↗ |
| K051443 | CERASORB DENTAL, CERASORB M DENTAL AND CERASORB PERIO | Curasan Ag, Frankfurt Facility | 2005-07-22 | Abbreviated | PDF ↗ |
| K042583 | CALC-I-OSS | Ultradent Products, Inc. | 2005-07-19 | Traditional | PDF ↗ |
| K051381 | ACE SURGICALPLASTER CALCIUM SULFACE HEMIHYDRATE | Ace Surgical Supply Co., Inc. | 2005-07-15 | Traditional | PDF ↗ |
| K050260 | BIORESORB MACRO PORE | Oraltronics Dental Implant Technology GmbH | 2005-07-15 | Traditional | PDF ↗ |
| K042730 | CALFORMA CALCIUM SULFATE BONE GRAFT BARRIER, MODEL 0.5G/1.0G | Lifecorebiomedical | 2005-02-14 | Traditional | PDF ↗ |
| K030052 | OSTIM | Heraeus Kulzer, Inc. | 2004-12-06 | Traditional | PDF ↗ |
| K042706 | OSSATURA DENTAL | Isotis Orthobiologics, Inc. | 2004-10-20 | Traditional | PDF ↗ |
| K040783 | FOUNDATION | Terumo Corp. | 2004-10-13 | Traditional | PDF ↗ |
| K031813 | OSSATURA DENTAL | Isotis NV | 2004-08-20 | Traditional | PDF ↗ |
| K041324 | CALMATRIX CALCIUM SULFATE BONE GRAFT BINDER | Lifecore Biomedical, Inc. | 2004-07-19 | Traditional | PDF ↗ |
| K030195 | BBP BONE SUBSTITUTES | Oct, USA, Inc. | 2004-06-17 | Traditional | PDF ↗ |
Product code LYC · Class II · Dental. Data: openFDA.