LYC — Bone Grafting Material, Synthetic Class II
Classification Details
- Product Code
- LYC
- Device Class
- Class II
- Regulation Number
- 872.3930
- Submission Type
- Review Panel
- DE
- Medical Specialty
- Dental
- Implant
- Yes
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K251818 | hudens bio co | BONTREE PLUS | March 6, 2026 |
| K244006 | full golden biotech co | FG Bone Graft M | September 17, 2025 |
| K243745 | full golden biotech corporation | FG Bone Graft B | August 29, 2025 |
| K241186 | shenzhen dazhou medical technology co | Synthetic Bone Graft Particulate | February 21, 2025 |
| K213260 | dimension inx | CMFlexTM | December 30, 2022 |
| K202675 | osteogene tech | InRoad® Dental Synthetic Bone Graft | March 4, 2022 |
| K201546 | revisios | OsOpia Synthetic Bone Void Filler | October 2, 2020 |
| K201051 | institut straumann | Straumann BoneCeramic | September 24, 2020 |
| K192597 | gc america | Cytrans Granules | August 17, 2020 |
| K153676 | genoss co | OSTEON III | September 14, 2016 |
| K153230 | implantech inc./shefabone | ShefaBone SCPC Resorbable Bone Graft | July 14, 2016 |
| K140374 | medtronic sofamor danek usa | MASTERGRAFT PUTTY | June 10, 2014 |
| K121177 | augma biomaterials | BOND APATITE | December 5, 2013 |
| K131385 | degradable solutions | EASY-GRAFT | September 27, 2013 |
| K111105 | curasan | CURASAN OSSEOLIVE DENTAL | December 20, 2012 |
| K113282 | riemser arzeimittel | CERASORB DENTAL,CERADORB M DENTAL, CERASORB PERIO | September 20, 2012 |
| K122240 | megagen implant co | BONE PLUS BCP EAGLE EYE | August 21, 2012 |
| K113049 | steiner laboratories | SOCKET GRAFT | January 27, 2012 |
| K112716 | genoss co | OSTEON II | January 17, 2012 |
| K110198 | blue sky bio | BLUE SKY BIO TCP | December 22, 2011 |