Browse hierarchy: [Dental (DE)](/submissions/DE) → [Subpart D — Prosthetic Devices](/submissions/DE/subpart-d%E2%80%94prosthetic-devices) → [21 CFR 872.3930](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/872.3930) → LYC — Bone Grafting Material, Synthetic # LYC · Bone Grafting Material, Synthetic _Dental · 21 CFR 872.3930 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/LYC ## Overview - **Product Code:** LYC - **Device Name:** Bone Grafting Material, Synthetic - **Regulation:** [21 CFR 872.3930](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/872.3930) - **Device Class:** 2 - **Review Panel:** [Dental](/submissions/DE) - **Implant:** yes ## Identification Bone grafting material is a material such as hydroxyapatite, tricalcium phosphate, polylactic and polyglycolic acids, or collagen, that is intended to fill, augment, or reconstruct periodontal or bony defects of the oral and maxillofacial region. ## Classification Rationale (1) Class II (special controls) for bone grafting materials that do not contain a drug that is a therapeutic biologic. The special control is FDA's “Class II Special Controls Guidance Document: Dental Bone Grafting Material Devices.” (See § 872.1(e) for the availability of this guidance document.) (2) Class III (premarket approval) for bone grafting materials that contain a drug that is a therapeutic biologic. Bone grafting materials that contain a drug that is a therapeutic biologic, such as biological response modifiers, require premarket approval. ## Special Controls *Classification.* (1) Class II (special controls) for bone grafting materials that do not contain a drug that is a therapeutic biologic. The special control is FDA's “Class II Special Controls Guidance Document: Dental Bone Grafting Material Devices.” (See § 872.1(e) for the availability of this guidance document.)(2) Class III (premarket approval) for bone grafting materials that contain a drug that is a therapeutic biologic. Bone grafting materials that contain a drug that is a therapeutic biologic, such as biological response modifiers, require premarket approval. (c) *Date premarket approval application (PMA) or notice of product development protocol (PDP) is required.* Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution. ## Recent Cleared Devices (20 of 229) Showing 20 most recent of 229 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K251818](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/LYC/K251818.md) | BONTREE PLUS | Hudens Bio Co., Ltd. | Mar 6, 2026 | SESE | | [K244006](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/LYC/K244006.md) | FG Bone Graft M | Full Golden Biotech Co., Ltd. | Sep 17, 2025 | SESE | | [K243745](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/LYC/K243745.md) | FG Bone Graft B | Full Golden Biotech Corporation | Aug 29, 2025 | SESE | | [K241186](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/LYC/K241186.md) | Synthetic Bone Graft Particulate | Shenzhen Dazhou Medical Technology Co., Ltd. | Feb 21, 2025 | SESE | | [K213260](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/LYC/K213260.md) | CMFlexTM | Dimension Inx Corp. | Dec 30, 2022 | SESE | | [K202675](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/LYC/K202675.md) | InRoad® Dental Synthetic Bone Graft | Osteogene Tech Corp | Mar 4, 2022 | SESE | | [K201546](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/LYC/K201546.md) | OsOpia Synthetic Bone Void Filler | Revisios BV | Oct 2, 2020 | SESE | | [K201051](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/LYC/K201051.md) | Straumann BoneCeramic | Institut Straumann AG | Sep 24, 2020 | SESE | | [K192597](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/LYC/K192597.md) | Cytrans Granules | GC America, Inc. | Aug 17, 2020 | SESE | | [K153676](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/LYC/K153676.md) | OSTEON III | Genoss Co., Ltd. | Sep 14, 2016 | SESE | | [K153230](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/LYC/K153230.md) | ShefaBone SCPC Resorbable Bone Graft | The Implantech Inc./Shefabone | Jul 14, 2016 | SESE | | [K140374](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/LYC/K140374.md) | MASTERGRAFT PUTTY | Medtronic Sofamor Danek USA, Inc. | Jun 10, 2014 | SESE | | [K121177](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/LYC/K121177.md) | BOND APATITE | Augma Biomaterials, Ltd. | Dec 5, 2013 | SESE | | [K131385](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/LYC/K131385.md) | EASY-GRAFT | Degradable Solutions AG | Sep 27, 2013 | SESE | | [K111105](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/LYC/K111105.md) | CURASAN OSSEOLIVE DENTAL | Curasan AG | Dec 20, 2012 | SESE | | [K113282](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/LYC/K113282.md) | CERASORB DENTAL,CERADORB M DENTAL, CERASORB PERIO | Riemser Arzeimittel AG | Sep 20, 2012 | SESE | | [K122240](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/LYC/K122240.md) | BONE PLUS BCP EAGLE EYE | Megagen Implant Co., Ltd. | Aug 21, 2012 | SESE | | [K113049](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/LYC/K113049.md) | SOCKET GRAFT | Steiner Laboratories | Jan 27, 2012 | SESE | | [K112716](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/LYC/K112716.md) | OSTEON II | Genoss Co., Ltd. | Jan 17, 2012 | SESE | | [K110198](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/LYC/K110198.md) | BLUE SKY BIO TCP | Blue Sky Bio, LLC | Dec 22, 2011 | SESE | ## Top Applicants - Bio-Interfaces, Inc. — 15 clearances - Ceramed Corp. — 13 clearances - Geistlich-Pharma — 11 clearances - Novabone Products, LLC — 9 clearances - Coors Biomedical Co. — 6 clearances --- **Source:** [https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/LYC](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/LYC) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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