Table 2. Dental bone graft substitutes which Food and Drug Administration (FDA) 510(k) approved.
| Product name | Approved date (mo/day/yr) | Indications with FDA 510(k) approved |
|---|---|---|
| Cerasorb M granules | 7/22/2005 | Alveolar augmentation |
| Filling of defects after root resection, apicoectomy, and cystectomy | ||
| Filling of extraction sockets | ||
| Elevation of the maxillary sinus floor | ||
| Filling of periodontal/perio-implant defects for GTR and GBR | ||
| MBCP | 12/11/2003 | Bone void filler for bony voids or gaps of the skeletal system |
| Used with autograft as a bone graft extender | ||
| Osseous defects and/or from traumatic injury to the bone. | ||
| Without initial mechanical properties. Therefore, rigid fixation techniques may often be recommended. Gradually resorbs and is replaced with bone. | ||
| MBCP Plus, MBCP+ | 7/30/2007 | Periodontal/infrabony defects |
| Ridge augmentation | ||
| Extraction site (for implant) | ||
| Sinus graft and cyst defect | ||
| OSTEON | 7/8/2010 | Periodontal/infrabony defects |
| Ridge augmentation | ||
| Extraction site (for implant) | ||
| Sinus lifts | ||
| Cystic cavities | ||
| OSTEON II | 12/26/2011 | Periodontal/infrabony defects |
| Ridge augmentation | ||
| Extraction site (implant preparation/placement) | ||
| Sinus lifts | ||
| Cystic cavities | ||
| OSTEON III | 9/14/2016 | Periodontal/infrabony defects |
| Ridge augmentation | ||
| Extraction site (implant preparation/placement) | ||
| Sinus lifts | ||
| Cystic cavities | ||
| TCP Dental | 11/10/2004 | Cystic cavities |
| Packed into bony voids or gaps of the skeletal system (such as the extremities, spine and the pelvis). | ||
| Osseous defects and/or from traumatic injury to the bone. | ||
| Resorbs and is replaced with bone during the healing process. | ||
| -Approved for KASIOS TCP not (KASIOS) TCP Dental |
(GTR: guided tissue regeneration, GBR: guided bone regeneration)