Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
LYC — Predicate Candidate Screening
231 FDA 510(k) clearances under this product code; the 50 most recent screened below.
104 daysmedian FDA review time
332 days90th percentile
231clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K253317 | Cytrans™ Elashield | GC America, Inc. | 2026-07-06 | 279 | 0 |
| K253883 | Bonalive Maxillofacial | Bonalive , Ltd. | 2026-05-14 | 161 | 0 |
| K251818 | BONTREE PLUS | Hudens Bio Co., Ltd. | 2026-03-06 | 266 | 0 |
| K244006 | FG Bone Graft M | Full Golden Biotech Co., Ltd. | 2025-09-17 | 265 | 0 |
| K243745 | FG Bone Graft B | Full Golden Biotech Corporation | 2025-08-29 | 267 | 0 |
| K241186 | Synthetic Bone Graft Particulate | Shenzhen Dazhou Medical Technology Co., Ltd. | 2025-02-21 | 298 | 0 |
| K213260 | CMFlexTM | Dimension Inx Corp. | 2022-12-30 | 456 | 0 |
| K202675 | InRoad® Dental Synthetic Bone Graft | Osteogene Tech Corp | 2022-03-04 | 535 | 0 |
| K201546 | OsOpia Synthetic Bone Void Filler | Revisios BV | 2020-10-02 | 115 | 0 |
| K201051 | Straumann BoneCeramic | Institut Straumann AG | 2020-09-24 | 156 | 0 |
| K192597 | Cytrans Granules | GC America, Inc. | 2020-08-17 | 332 | 0 |
| K153676 | OSTEON III | Genoss Co., Ltd. | 2016-09-14 | 268 | 0 |
| K153230 | ShefaBone SCPC Resorbable Bone Graft | The Implantech Inc./Shefabone | 2016-07-14 | 251 | 0 |
| K140374 | MASTERGRAFT PUTTY | Medtronic Sofamor Danek USA, Inc. | 2014-06-10 | 116 | 0 |
| K121177 | BOND APATITE | Augma Biomaterials, Ltd. | 2013-12-05 | 596 | 0 |
| K131385 | EASY-GRAFT | Degradable Solutions AG | 2013-09-27 | 136 | 0 |
| K111105 | CURASAN OSSEOLIVE DENTAL | Curasan AG | 2012-12-20 | 610 | 0 |
| K113282 | CERASORB DENTAL,CERADORB M DENTAL, CERASORB PERIO | Riemser Arzeimittel AG | 2012-09-20 | 318 | 0 |
| K122240 | BONE PLUS BCP EAGLE EYE | Megagen Implant Co., Ltd. | 2012-08-21 | 25 | 0 |
| K113049 | SOCKET GRAFT | Steiner Laboratories | 2012-01-27 | 106 | 0 |
| K112716 | OSTEON II | Genoss Co., Ltd. | 2012-01-17 | 120 | 0 |
| K110198 | BLUE SKY BIO TCP | Blue Sky Bio, LLC | 2011-12-22 | 332 | 0 |
| K112428 | NOVABONE DENTAL MORSELS - BIOACTIVE SYNTHETIC BONE GRAFT | Novabone Products, LLC | 2011-12-16 | 115 | 0 |
| K111087 | FOUNDATION | Olympus Terumo Biomaterials Corporation | 2011-11-29 | 224 | 0 |
| K103820 | REPROBONE DENTAL GRAFTING MATERIAL | Ceramisys, Ltd. | 2011-11-03 | 308 | 0 |
| K110449 | ENDOBON XENOGRAFT GRANULES | Biomet 3i | 2011-05-13 | 86 | 1 |
| K102208 | NANOGEN | Orthogen, LLC | 2011-05-06 | 274 | 0 |
| K101827 | OSTEOSCAF | Texas Innovative Medical Devices (Dba) Skeletal | 2011-04-20 | 293 | 0 |
| K103709 | CERACELL DENTAL | Curasan AG | 2011-03-10 | 80 | 0 |
| K102872 | OSBONE DENTAL | Curasan AG | 2011-01-12 | 104 | 0 |
| K100883 | CARRIGEN | Etex Corp. | 2010-12-21 | 266 | 0 |
| K102812 | GAMMA-BSM; BETA-BSM; EQUIVABONE | Etex Corporation | 2010-12-03 | 66 | 0 |
| K102015 | OSTEON, OSTEON SINUS, OSTEON LIFTING | Genoss Co., Ltd. | 2010-11-19 | 126 | 0 |
| K101718 | OSSEOCONDUCT | Steiner Laboratories Div of Steiner Healthcare, LLC | 2010-10-26 | 130 | 0 |
| K101014 | BOND BONE | Mis Implants Technologies , Ltd. | 2010-10-21 | 192 | 0 |
| K091618 | VITOMATRIX | Orthovita, Inc. | 2010-09-27 | 481 | 0 |
| K101426 | CEROS TCP GRANULES | Mathys, Ltd. | 2010-09-15 | 117 | 0 |
| K090950 | BONE PLUS BCP | Megagen Implant Co., Ltd. | 2010-07-02 | 455 | 0 |
| K092194 | POLYBONE DENTAL | Kyung Won Medical Co., Ltd. | 2010-06-16 | 330 | 0 |
| K093390 | HEALOS DENTAL BONE GRAFT SUBSTITUTE (ALSO CALLED HEALOS OR H | Depuy Spine, Inc. | 2010-05-25 | 208 | 0 |
| K093871 | PERIOPHIL B-TCP | Cytophil, Inc. | 2010-04-22 | 126 | 0 |
| K100671 | NOVABONE DENTAL PUTTY-BIOACTIVE SYNTHETIC BONE GRAFT | Novabone Products, LLC | 2010-03-30 | 21 | 0 |
| K093122 | MBCP+ | Biomatlante | 2010-03-15 | 164 | 0 |
| K092087 | MEDTRONIC DENTAL TCP | Medtronic Sofamor Danek USA, Inc. | 2009-12-30 | 174 | 0 |
| K091729 | ALPHA-BSM, BETA-BSM, GAMMA-BSM, EQUIVABONE | Etex Corp. | 2009-12-23 | 195 | 0 |
| K092788 | PERIOPHIL BIPHASIC | Cytophil, Inc. | 2009-12-18 | 99 | 1 |
| K083372 | ARROWBONE-A, ARROWBONE-B | Brainbase Corporation | 2009-12-08 | 389 | 0 |
| K092567 | MODIFICATION TO UNIGRAFT | Unicare Biomedical, Inc. | 2009-11-25 | 97 | 0 |
| K090850 | ACTIFUSE BONE GRAFT SUBSTITUTE, ACTIFUSE MICROGRANULES BONE | Apatech , Ltd. | 2009-07-30 | 122 | 0 |
| K091484 | NOVABONE DENTAL PUTTY - BIOACTIVE SYNTHETIC BONE GRAFT | Novabone Products, LLC | 2009-06-15 | 27 | 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