← Product Code [LYC](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/LYC) · K243745 # FG Bone Graft B (K243745) _Full Golden Biotech Corporation · LYC · Aug 29, 2025 · Dental · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/LYC/K243745 ## Device Facts - **Applicant:** Full Golden Biotech Corporation - **Product Code:** [LYC](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/LYC.md) - **Decision Date:** Aug 29, 2025 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 872.3930 - **Device Class:** Class 2 - **Review Panel:** Dental - **Attributes:** Therapeutic ## Intended Use FG Bone Graft B is recommended for: • Augmentation or reconstructive treatment of the alveolar ridge. • Filling of infrabony periodontal defects. • Filling of defects after root resection, apicoectomy, and cystectomy. • Filling of extraction sockets to enhance preservation of the alveolar ridge. • Elevation of the maxillary sinus floor. • Filling of periodontal defects in conjunction with products intended for Guided Tissue Regeneration (GTR) and Guided Bone Regeneration (GBR). • Filling of peri-implant defects in conjunction with products intended for Guided Bone Regeneration (GBR). ## Device Story FG Bone Graft B is a sterile, synthetic, multi-porous beta-tricalcium phosphate (β-TCP) ceramic matrix in granular form. Used as a bone void filler in dental applications; applied by clinicians to fill bone defects. Material supports rapid ossification and undergoes resorption over time. Device is provided in granular form; implanted into surgical sites (e.g., alveolar ridge, sinus floor). Clinical benefit includes structural support for bone regeneration and preservation of alveolar ridge volume. Performance is evaluated via histological and radiographic analysis of bone formation and material degradation rates. Device is substantially equivalent to existing synthetic bone void fillers. ## Clinical Evidence Bench testing and animal study (Beagle dog model) performed. Animal study evaluated bone healing and material degradation at 4, 8, and 12 weeks in alveolar defect models. Endpoints included histological quantification of new bone formation, material resorption rates, and inflammatory response. Results showed new bone formation and degradation rates comparable to the predicate (Cerasorb). Minimal to mild inflammatory response observed. No human clinical data provided. ## Technological Characteristics Synthetic beta-tricalcium phosphate (β-TCP) ceramic matrix; phase purity ≥ 99%; complies with ASTM F 1088-04. Granular form (500-1000 μm); volumetric porosity ~68.3%; Ca/P ratio 1.89-1.95. Sterilized via gamma irradiation (SAL 10⁻⁶). Standalone implantable material. ## Regulatory 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. ## 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. ## Predicate Devices - CERASORB M DENTAL ([K051443](/device/K051443.md)) ## Related Devices - [K081561](/device/K081561.md) — OSFERION D · Olympus Terumo Biomaterials Corporation · Jul 28, 2008 - [K083372](/device/K083372.md) — ARROWBONE-A, ARROWBONE-B · Brainbase Corporation · Dec 8, 2009 - [K244006](/device/K244006.md) — FG Bone Graft M · Full Golden Biotech Co., Ltd. · Sep 17, 2025 - [K120152](/device/K120152.md) — CERASORB PLUS · Riemser Arzneimittel AG · Aug 13, 2012 - [K050260](/device/K050260.md) — BIORESORB MACRO PORE · Oraltronics Dental Implant Technology GmbH · Jul 15, 2005 ## Submission Summary (Full Text) {0} FDA U.S. FOOD & DRUG ADMINISTRATION August 29, 2025 Full Golden Biotech Corporation % Yvonne Chen Regulatory Affairs Consultant Voler Biotech Consulting CO., Ltd 6F.-17, No. 14, Ln. 609, Sec. 5, Chongxin Rd., Sanchong Dist New Taipei City, 241407 TAIWAN Re: K243745 Trade/Device Name: FG Bone Graft B Regulation Number: 21 CFR 872.3930 Regulation Name: Bone Grafting Material Regulatory Class: Class II Product Code: LYC Dated: November 29, 2024 Received: July 30, 2025 Dear Yvonne Chen: We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov {1} K243745 - Yvonne Chen Page 2 Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download). Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181). Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050. All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems. {2} K243745 - Yvonne Chen Page 3 For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, Sherrill Lathrop Blitzer for Andrew Steen Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT, and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {3} FORM FDA 3881 (8/23) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF | DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use | Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below. | | --- | --- | | 510(k) Number (if known) K243745 | | | Device Name FG Bone Graft B | | | Indications for Use (Describe) FG Bone Graft B is recommended for: • Augmentation or reconstructive treatment of the alveolar ridge. • Filling of infrabony periodontal defects. • Filling of defects after root resection, apicoectomy, and cystectomy. • Filling of extraction sockets to enhance preservation of the alveolar ridge. • Elevation of the maxillary sinus floor. • Filling of periodontal defects in conjunction with products intended for Guided Tissue Regeneration (GTR) and Guided Bone Regeneration (GBR). • Filling of peri-implant defects in conjunction with products intended for Guided Bone Regeneration (GBR). | | | Type of Use (Select one or both, as applicable) ☑ Prescription Use (Part 21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C) | | | CONTINUE ON A SEPARATE PAGE IF NEEDED. | | | This section applies only to requirements of the Paperwork Reduction Act of 1995. *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* | | | The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov | | | "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." | | {4} 510(k) Summary # 510(k) SUMMARY ## 1. Submission Information Submitter: Full Golden Biotech Co., Ltd. 3F., No. 27, Sec. 2, Henan Rd., Xitun Dist., Taichung City 407, Taiwan (R.O.C.) Submitter contact: Mr. Chiyu Chen Tel: +886-912182578 E-mail: cinseagle@gmail.com Date prepared: August 29, 2025 ## 2. Device Name and Classification Product Name: FG Bone Graft B (BB-01001/BB-01002/BB-02001/BB-02002) Classification Name: Bone Grafting Material, Synthetic Common or Usual Name: Bone Void Filler, Synthetic Regulation Number: 872.3930 Product Code: LYC ## 3. Predicate Device(s) Product Name: CERASORB M DENTAL (K051443) Common or Usual Name: Bone Void Filler, Synthetic Regulation Number: 872.3930 Product Code: LYC ## 4. Device Description FG Bone Graft B is a sterile, synthetic, multi-porous biocompatible ceramic matrix in granular form for filling bone defects. The material with microporous structure supports rapid ossification with local bone. With its phase purity of ≥ 99%, the ceramic material complies with US standard specification ASTM F 1088-04. The validated manufacturing process guarantees batch conformity and reproducibility. ## 5. Indications for Use FG Bone Graft B is recommended for: - Augmentation or reconstructive treatment of the alveolar ridge. - Filling of infrabony periodontal defects. - Filling of defects after root resection, apicoectomy, and cystectomy. {5} 510(k) Summary - Filling of extraction sockets to enhance preservation of the alveolar ridge. Elevation of the maxillary sinus floor. - Filling of periodontal defects in conjunction with products intended for Guided Tissue Regeneration (GTR) and Guided Bone Regeneration (GBR). - Filling of peri-implant defects in conjunction with products intended for Guided Bone Regeneration (GBR). 6. Comparison to the Predicate Device | Items | Predicate Device | Proposed Device | Brief Comparison | | --- | --- | --- | --- | | Device Name (Common name) | CERASORB M DENTAL | FG Bone Graft B | - | | K. number | K051443 | K243745 | - | | Regulation Number | 21 CFR 872.3930 | 21 CFR 872.3930 | Substantially equivalent | | Product code | LYC | LYC | Substantially equivalent | | Intended Use | • Augmentation or reconstructive treatment of the alveolar ridge. • Filling of infrabony periodontal defects. • Filling of defects after root resection, apicoectomy, and cystectomy. • Filling of extraction sockets to enhance preservation of the alveolar ridge. • Elevation of the maxillary sinus floor. • Filling of periodontal defects in conjunction with products intended for Guided Tissue Regeneration (GTR) and Guided Bone | • Augmentation or reconstructive treatment of the alveolar ridge. • Filling of infrabony periodontal defects. • Filling of defects after root resection, apicoectomy, and cystectomy. • Filling of extraction sockets to enhance preservation of the alveolar ridge. • Elevation of the maxillary sinus floor. • Filling of periodontal defects in conjunction with products intended for Guided Tissue Regeneration (GTR) and Guided Bone | Substantially equivalent | {6} 510(k) Summary | Items | Predicate Device | Proposed Device | Brief Comparison | | --- | --- | --- | --- | | | Regeneration (GBR). • Filling of peri-implant defects in conjunction with products intended for Guided Bone Regeneration (GBR). | Regeneration (GBR). • Filling of peri-implant defects in conjunction with products intended for Guided Bone Regeneration (GBR). | | | Main Components | Beta-tricalcium phosphate Ca₃(PO₄)₂ | Beta-tricalcium phosphate Ca₃(PO₄)₂ | Substantially equivalent | | Other Significant Components | Polyethylene Sucrose | Polyethylene Sucrose | Substantially equivalent | | Sterilization Method | Gamma irradiation | Gamma irradiation | Substantially equivalent | | Sterility Assurance Level (SAL) | 10⁻⁶ | 10⁻⁶ | Substantially equivalent | | Biocompatibility | Biocompatible | - ISO 10993-5 (Cytotoxicity) - ISO 10993-10 (Intracutaneous reactivity) - ISO 10993-10 (Skin sensitization) - ISO 10993-11, USP 151 (Pyrogen) - ISO 10993-11 (Acute systemic toxicity) - ISO 10993-6, ISO 10993-11 (Repeat-dose subacute systemic toxicity) - ISO 10993-6 (Bone implant) - ISO 10993-3 (Genotoxicity) | Substantially equivalent | | Performance | Compliance with Special Controls Guidance document | - Particle size: 500-1000 μm - Ca/P ratio: 1.89 - 1.95 | Substantially equivalent | {7} 510(k) Summary | Items | Predicate Device | Proposed Device | Brief Comparison | | --- | --- | --- | --- | | | | - Volumetric porosity: 68.3% - pH: ~7.9 over 7 days | | FG Bone Graft B has similar technological characteristics as the predicate devices including overall design, intended use, material composition, function, and range of sizes. Even though the manufacturing methods are different, this does not affect the same acceptability attributes between the product and the predicates and does not cause new issue relating to the safety or performance. The performance data demonstrate that the new devices are substantially equivalent to the predicate device and meet the requirements of the Special Controls Guidance document. # 7. Performance Data Non-clinical tests were performed on the proposed device. The following tests were conducted: A. Chemical Composition | Description | Criteria | | Result | | | --- | --- | --- | --- | --- | | Complete chemical composition, summing to 100% by mass, including all additives and the Chemical Abstracts Service13 (CAS®) registry number of all components. | consisting of ≥ 99% beta-Tricalcium Phosphate (β-TCP) | | 100% | | | Description of the composition, including an elemental analysis, | Conc.(ppm) | | Conc.(ppm) | | | | Pb | ≤30 | Pb | 0 | | | As | ≤3 | As | 0.33 | | | Cd | ≤5 | Cd | 0.09 | | | Hg | ≤5 | Hg | 0 | {8} 510(k) Summary B. Physical Properties | Description | Criteria | Result | | --- | --- | --- | | SEM micrographs, showing particle size, shape, and porosity | The product behaves like a porous structure and is similar to the reference product. | - The SEM result showed the surface characteristic of the TCP sample (FG Bone Graft B) is similar structure as predicate device (Cerasorb) via 600X, 1000X and 3000x SEM photo. | | A plot of the resorption of your device versus time showing the time for total clearance or integration under a representative model | Similar trend changes to the comparison products. | ~90% degraded by 12 weeks | | Healing time, i.e., the earliest time at which implant loading may be successfully attempted | N/A | The defect fill rate was observed to be 21.5% at 4 weeks, increasing to 26.2% by 8 weeks, and reaching up to 33.9% by 12 weeks. | | Phase purity, i.e., the relative mass percentages of | Similar trend changes to the comparison products. | 100% β-TCP | | the relative mass percentage of the material | | | {9} 510(k) Summary | crystalline and amorphous phases (%) | | | | --- | --- | --- | | Calcium to phosphorous ratio (Ca/P) | Ca/P ratio >1.5 | Ca/P ratio: 1.89 - 1.95 | | Volumetric porosity (% void space) | The porosity is approximately 70% ± 5% or similar to the reference product. | Volumetric porosity: 68.3% | | Particle size distribution plot (μ) | The mean value of the particle size distribution is within the declared specifications, or the median and mode are within the specification range. | 500-1000 μm | | pH | Similar trend changes to the comparison products. | ~7.9 over 7 days | {10} 510(k) Summary ## C. Performance In Vivo ### 1. Test model: - Animal model: Beagle dog, Male, 12-18 months of age. - Study design: evaluate bone healing and material degradation at 4, 8, and 12 weeks. Animals were divided into groups: test group (FG Bone Graft B), positive control group (Cerasorb, a commercial β-TCP), and a negative control (empty defect). ### 2. Defect type: - Dental application: The study simulated alveolar bone defects (e.g., post-extraction bone loss) or maxillary sinus augmentation models. Single-walled defects (incomplete truncation, "L" shaped couch, 10 mm in length, 5 mm in width and 5 mm in depth) were designed to prevent spontaneous healing. - Creation method: Defects were created surgically using standardized tools (Dental handpiece) to ensure consistent size and shape across groups, following aseptic techniques and animal welfare protocols. ### 3. Treatment methods - Test article: FG Bone Graft B - Control article: Cerasorb - Application method: Applied as granules to fill the bone defect. - Dosage: Material volume (0.25 cm³) was determined based on defect size to ensure complete filling, consistent with standard protocols. ### 4. Endpoints assessed - Histological analysis: a) New bone formation: Quantification of new bone area or volume within the defect site, assessed via Masson-Goldner staining. b) Material degradation: Measurement of residual FG Bone Graft B and Cerasorb, expressed as a percentage of remaining material, to assess resorption rates. c) Inflammatory response: Evaluation of inflammatory cell infiltration (e.g., lymphocytes, macrophages) or adverse tissue reactions to the graft material. - Radiographic analysis: Included micro-CT to assess bone density and bone volume. ### 5. Results - New bone formation: New bone formation increased over time at comparable rates to the predicate. - Material degradation: FG Bone Graft B degraded at comparable rates to the predicate over 12 weeks. {11} 510(k) Summary - Inflammatory response: Minimal to mild inflammatory response, with no significant adverse reactions. ## Conclusion Test data indicate that the final properties of FG Bone Graft B are in compliance with the guidance for Bone Grafting Material Devices and are substantially equivalent to the predicate device. --- **Source:** [https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/LYC/K243745](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/LYC/K243745) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite as:** FDA Device Explorer (Innolitics), https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/LYC/K243745