LYC — Bone Grafting Material, Synthetic Class II
FDA product code LYC covers "Bone Grafting Material, Synthetic", a Class II medical device regulated under 21 CFR 872.3930. Submissions are reviewed by the Dental panel. Devices under this code are implants. At least 20 recent 510(k) clearances have been granted under this product code.
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 |
|---|---|---|---|
| K253317 | gc america | Cytrans Elashield | July 6, 2026 |
| K253883 | bonalive | Bonalive Maxillofacial | May 14, 2026 |
| 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 |