LYC · Bone Grafting Material, Synthetic
Dental · 21 CFR 872.3930 · Class 2
Overview
| Product Code | LYC |
|---|---|
| Device Name | Bone Grafting Material, Synthetic |
| Regulation | 21 CFR 872.3930 |
| Device Class | Class 2 |
| Review Panel | Dental |
| 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 | BONTREE PLUS | Hudens Bio Co., Ltd. | Mar 6, 2026 | SESE |
| K244006 | FG Bone Graft M | Full Golden Biotech Co., Ltd. | Sep 17, 2025 | SESE |
| K243745 | FG Bone Graft B | Full Golden Biotech Corporation | Aug 29, 2025 | SESE |
| K241186 | Synthetic Bone Graft Particulate | Shenzhen Dazhou Medical Technology Co., Ltd. | Feb 21, 2025 | SESE |
| K213260 | CMFlexTM | Dimension Inx Corp. | Dec 30, 2022 | SESE |
| K202675 | InRoad® Dental Synthetic Bone Graft | Osteogene Tech Corp | Mar 4, 2022 | SESE |
| K201546 | OsOpia Synthetic Bone Void Filler | Revisios BV | Oct 2, 2020 | SESE |
| K201051 | Straumann BoneCeramic | Institut Straumann AG | Sep 24, 2020 | SESE |
| K192597 | Cytrans Granules | GC America, Inc. | Aug 17, 2020 | SESE |
| K153676 | OSTEON III | Genoss Co., Ltd. | Sep 14, 2016 | SESE |
| K153230 | ShefaBone SCPC Resorbable Bone Graft | The Implantech Inc./Shefabone | Jul 14, 2016 | SESE |
| K140374 | MASTERGRAFT PUTTY | Medtronic Sofamor Danek USA, Inc. | Jun 10, 2014 | SESE |
| K121177 | BOND APATITE | Augma Biomaterials, Ltd. | Dec 5, 2013 | SESE |
| K131385 | EASY-GRAFT | Degradable Solutions AG | Sep 27, 2013 | SESE |
| K111105 | CURASAN OSSEOLIVE DENTAL | Curasan AG | Dec 20, 2012 | SESE |
| K113282 | CERASORB DENTAL,CERADORB M DENTAL, CERASORB PERIO | Riemser Arzeimittel AG | Sep 20, 2012 | SESE |
| K122240 | BONE PLUS BCP EAGLE EYE | Megagen Implant Co., Ltd. | Aug 21, 2012 | SESE |
| K113049 | SOCKET GRAFT | Steiner Laboratories | Jan 27, 2012 | SESE |
| K112716 | OSTEON II | Genoss Co., Ltd. | Jan 17, 2012 | SESE |
| K110198 | 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
