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 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.

AI/ML Overview

The FDA 510(k) clearance letter for FG Bone Graft B indicates that the device is substantially equivalent to a predicate device (CERASORB M DENTAL). The clearance letter references non-clinical tests performed to demonstrate this equivalence, focusing on chemical composition, physical properties, and performance in vivo.

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Description	Acceptance Criteria	Reported Device Performance and Results
Chemical Composition
Complete chemical composition, summing to 100% by mass, including all additives and the Chemical Abstracts Service (CAS®) registry number of all components.	Consisting of ≥ 99% beta-Tricalcium Phosphate (ß-TCP)	100%
Description of the composition, including an elemental analysis, identifying the trace impurities.	Conc.(ppm) Pb ≤30, As ≤3, Cd ≤5, Hg ≤5	Conc.(ppm) Pb 0, As 0.33, Cd 0.09, Hg 0
Physical Properties
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 in structure to the predicate device (Cerasorb) via 600X, 1000X, and 3000x SEM photos.
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 (Not explicitly defined as a numerical criterion, but evaluated in vivo).	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. (This implies a healing progression, though not a specific "loading time" metric).
Phase purity, i.e., the relative mass percentages of crystalline and amorphous phases (%).	Similar trend changes to the comparison products.	100% β-TCP
Calcium to phosphorus 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.	500-1000μm
pH.	Similar trend changes to the comparison products.	~7.9 over 7 days
Performance In Vivo
New bone formation.	New bone formation performance comparable to the predicate.	New bone formation increased over time at comparable rates to the predicate.
Material degradation (residual material).	Material degradation rates comparable to the predicate.	FG Bone Graft B degraded at comparable rates to the predicate over 12 weeks.
Inflammatory response.	Minimal to mild inflammatory response, no significant adverse reactions.	Minimal to mild inflammatory response, with no significant adverse reactions.

2. Sample Size Used for the Test Set and Data Provenance

Sample size for the test set: The document states that the in vivo study used a "Beagle dog" model, and the 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)." However, the exact number of animals in each group or total animal count is not specified in the provided text.
Data provenance: The study was a prospective in vivo animal study performed on Beagle dogs. The location/country of origin of the study is not explicitly stated in the provided text, but the submitter "Full Golden Biotech Co., Ltd." is located in Taiwan.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

Number of experts: Not explicitly stated. The histological and radiographic analyses were likely performed by trained professionals (e.g., veterinary pathologists, radiologists), but the number of reviewers or their specific qualifications are not detailed in the provided text.
Qualifications of experts: Not specified beyond the implied expertise in conducting and analyzing in vivo studies (e.g., histology, micro-CT).

4. Adjudication Method for the Test Set

Adjudication method: Not explicitly stated. For animal studies, consistency and blinding are typically employed, but a formal "adjudication method" in the sense of multiple human readers for consensus is not described for this non-AI bone graft device. The results are presented as quantitative measurements and observations (e.g., "new bone formation increased," "minimal to mild inflammatory response").

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

MRMC study: No, an MRMC comparative effectiveness study was not done. This type of study is typically performed for AI/image analysis devices where the AI's impact on human reader performance is being assessed. This document describes a traditional preclinical performance study for a bone graft material.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done

Standalone performance: N/A. This is a bone graft material, not an algorithm or AI device. The "performance" refers to the biological and physical properties of the material itself, not the output of a software algorithm.

7. The Type of Ground Truth Used

Type of ground truth: The ground truth for the in vivo study (which is the primary performance study) was established through direct anatomical, histological, and radiographic assessments of the bone defects in the animal model.
- Histological analysis: Quantified new bone formation, material degradation, and inflammatory response. This involves microscopic examination of stained tissue sections, which is considered a gold standard for assessing tissue regeneration and integration.
- Radiographic analysis: Used micro-CT to assess bone density and bone volume, providing quantitative structural data.
- Comparison to predicate: The "ground truth" for showing substantial equivalence was the performance of the established predicate device (Cerasorb) under the same study conditions.

8. The Sample Size for the Training Set

Sample size for training set: N/A. This device is a bone graft material, not an AI or machine learning algorithm. Therefore, there is no "training set."

9. How the Ground Truth for the Training Set was Established

Ground truth for training set: N/A. As there is no AI component, there is no training set and no ground truth establishment for such a set.

Summary

FDA 510(k) Clearance Letter - FG Bone Graft B

Page 1

U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

Doc ID # 04017.08.00

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.

August 29, 2025

Page 2

U.S. FOOD & DRUG ADMINISTRATION

August 29, 2025

Dear Yvonne Chen:

U.S. Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

Page 3

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.

Page 4

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

Page 5

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"

FORM FDA 3881 (8/23) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF

Page 6

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026

Indications for Use

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.

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"

FORM FDA 3881 (8/23) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF

Page 7

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.

Page 8

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

Page 9

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 Regeneration (GBR).• Filling of peri-implant defects in conjunction with products intended for Guided Bone Regeneration (GBR).	• 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).	Substantially equivalent

Page 10

Items	Predicate Device	Proposed Device	Brief Comparison
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: 500-1000μm- Ca/P ratio: 1.89 - 1.95	Substantially equivalent

Page 11

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: 500-1000μm- Ca/P ratio: 1.89 - 1.95	Substantially equivalent

Page 12

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 (ß-TCP)	100%
Description of the composition, including an elemental analysis,	Conc.(ppm)Pb ≤30As ≤3Cd ≤5Hg ≤5	Conc.(ppm)Pb 0As 0.33Cd 0.09Hg 0

Page 13

Description	Criteria	Result
identifying the trace impurities.

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

Page 14

Description	Criteria	Result
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.	500-1000μm
pH	Similar trend changes to the comparison products.	~7.9 over 7 days

Page 15

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.

Page 16

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.

Regulation Number and Section

§ 872.3930 Bone grafting material.

(a)
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.(b)
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.