This guidance document is intended to assist registration applicants in preparing and drafting registration application materials for oral bone graft materials used in dental implantation. It also serves as a technical reference for regulatory authorities during the technical review of registration application materials.

This guidance represents general requirements for registration application materials of oral bone graft materials used in dental implantation. Applicants should determine the applicability of its contents based on the specific characteristics of their products. If certain parts are not applicable, applicants must provide detailed explanations of the reasons along with corresponding scientific evidence, and supplement or refine the registration application materials according to the specific characteristics of the product.

This guidance is a reference document for both registration applicants and technical reviewers. It does not cover administrative matters related to review and approval processes, nor is it mandatory for enforcement as regulation. It should be used in compliance with relevant regulations and mandatory standards. Alternative approaches that meet regulatory requirements may also be adopted, provided that detailed research data and verification materials are submitted.

This guidance is established based on current regulations, standards, and the present level of scientific understanding. As regulations and standards continue to evolve and science and technology advance, relevant content of this guidance will be adjusted accordingly.

I. Scope of Application

The oral bone graft materials for dental implantation covered in this guidance are typically used in conjunction with membrane materials during dental implant procedures to reconstruct alveolar bone tissue in the implant area of edentulous patients, addressing insufficient horizontal or vertical bone volume in the implant area. Specific applications include: socket filling after tooth extraction or residual root removal; alveolar ridge restoration; and repair of alveolar bone defects caused by periodontal diseases.

Oral bone graft materials for dental implantation include natural bone graft materials and synthetic bone graft materials. Natural bone graft materials comprise allogeneic bone and xenogeneic bone (animal-derived bone). Synthetic bone graft materials include calcium phosphate-based bioceramics (such as hydroxyapatite, β-tricalcium phosphate, etc.) and calcium silicate-based bioactive glass. This guidance applies to animal-derived xenogeneic bone implant materials processed through degreasing, deproteinization, calcination, and other manufacturing processes.

For allogeneic bone materials, calcium phosphate-based bioceramics, and calcium silicate-based bioactive glass oral bone graft materials for dental implantation, reference may be made to the "Guidance for Technical Review of Viral Inactivation Process Validation for Allogeneic Implantable Medical Devices," "Guidance for Technical Review of Calcium Phosphorus/Silicon-Based Bone Filler Materials Registration," and applicable sections of this document.

For composite bone graft materials containing organic components (such as collagen) or additives (such as sodium carboxymethyl cellulose, sodium hyaluronate, glycerol, etc.), or bone filler materials containing growth factors or nanomaterials, reference may be made to applicable sections.

II. Key Points for Registration Review

(I) Regulatory Information

1. Product Name

The product name should adopt the common name from national or industry standards, or be named based on the product's intended clinical use or application site, in compliance with relevant regulations such as the "Rules for Naming Medical Device General Names" and the "Guidance for General Naming of Dental Instruments." The product characteristic words may include "repair," "filling," etc., based on technical features, and "oral," etc., based on clinical application site. Examples include: oral bone filling material, oral bone repair material, etc.

2. Classification Code

Based on the "Medical Device Classification Catalog," specify the product management category, classification subdirectory name, primary product category, secondary product category, and classification code. According to the intended use and mechanism of action, oral bone graft materials for dental implantation are Class III medical devices, belonging to "17 Dental Instruments," with the primary product category as "17-08 Dental Implant and Tissue Reconstruction Materials," and the secondary product category as "17-08-06 Bone Filling and Repair Materials."

3. Principles for Registration Unit Division

The division of product registration units must comply with the requirements of the "Guidance for Division of Medical Device Registration Units." In principle, the division of medical device product registration units is based on technical principles, structural composition, performance indicators, and scope of application. When raw materials come from different sources, they should be divided into different registration units; when differences in structural composition or processing methods lead to different performance indicators, they should in principle be divided into different registration units.

For example, when raw materials come from different biological species, such as bovine bone and porcine bone-derived products, they should be divided into different registration units; for the same biological source but different tissue sources, such as bovine femur and bovine rib tissue sources, they should be divided into different registration units; for the same biological source but different preparation processes, such as material-modified versus non-modified, they should be divided into different registration units.

4. Product List

Clearly describe the model and specification representation method of the declared product, and specify the division principles for models and specifications. For products with multiple models and specifications, clearly describe the differences between them. Use comparison tables or illustrative images, charts with explanatory text to describe the structural composition, functions, product features, technical parameters, etc., of various models and specifications.

(II) Overview Documentation

1. Device and Operation Principle Description

Describe the raw materials of the product (for animal-derived products, specify the tissue type, collection site, species, geographical source, age, etc.), structure and composition, usage method with illustrations, and compatible instruments. Provide overall/local structural diagrams of the product (such as particle size of powder, shape and size of blocks, etc.), scanning electron microscope photos (such as surface structure, pore characteristics), and product degradation information (including degradation mechanism, degradation products, expected degradation time). Specify the delivery state, sterilization method, and sterile shelf life of the product.

Describe the intended use, working principle, or mechanism of action of the product.

2. Product Indications and Contraindications

The indications, applicable populations, and contraindications of the product should be consistent with the performance and functions of the declared product.

2.1 Indications

The description of indications should be objective and clear, using well-defined or industry-recognized terms or names. For example: The product is used in conjunction with barrier membranes and is suitable for bone defect repair in dental surgery, including: socket filling after tooth extraction and residual root removal; alveolar ridge restoration; and repair of alveolar bone defects caused by periodontal diseases.

2.2 Expected Use Environment

Specify the expected use location (e.g., medical institutions) and describe environmental conditions that may affect its safety and effectiveness.

2.3 Applicable Population

Clearly describe the target patient population information, patient selection criteria, and factors to be considered during use.

2.4 Contraindications

After risk/benefit assessment, clearly specify diseases, conditions, or specific populations (if applicable) for which the product is not recommended.

3. Packaging Description

Provide product packaging information, including packaging form, packaging materials, and packaging process. Use a combination of images and text to clearly indicate the packaging information of the declared product, and list all packaging contents in tabular form. Typically, such products are provided in a sterile state. The applicant must provide detailed information about the sterile barrier system compatible with the product sterilization method.