The standards for materials used in BeDental Dentistry follow the International Organization for Standardization (ISO) specifically as follows:

1. Restorative Materials

Aesthetic dental restorative materials are one of the critical fields in dentistry, requiring materials to meet many high technical and aesthetic requirements. To ensure product quality and meet user needs, aesthetic dental restorative materials in dentistry need to meet the following criteria according to ISO standards:

• Biocompatibility: Materials must ensure safety for the user’s health. ISO 10993 regulates the biological evaluation requirements of medical materials, including dental restorative materials.
• Adhesion: Materials must have the ability to bond tightly and durably to teeth and surrounding soft tissues. ISO 4049 regulates the adhesion requirements of elastomeric polymer restorative materials.
• Aesthetics: Materials must have high aesthetic value, ensuring the ability to recreate the shape and color of natural teeth. ISO 7491 regulates the requirements for color and transparency of restorative materials.
• Durability: Materials must have high durability to ensure stability and reliability during use. ISO 1567 and ISO 6872 regulate the durability requirements of metal and ceramic restorative materials.
• Ease of use: Materials must be easy to use and convenient for dentists and dental technicians. ISO 10477 regulates the mechanical and chemical performance requirements of composite restorative materials.

These criteria help ensure the safety, efficiency, and aesthetics of aesthetic dental restorative materials in dentistry, while meeting technical requirements and quality standards.

2. Filling Materials

To ensure quality and safety for users, dental filling materials need to meet the following criteria according to international ISO standards:

• Biocompatibility: Materials must be fully evaluated for biological safety, ensuring no harm to the user’s health. ISO 10993 regulates biological evaluation requirements for medical materials, including filling materials.
• Adhesion: Materials must be able to bond tightly to tooth tissue and remain stable over a long period. ISO 4049 regulates the adhesion requirements of polymer filling materials.
• Aesthetics: Materials must have high aesthetic value, ensuring the ability to recreate the shape and color of natural teeth. ISO 7491 regulates the color and transparency requirements of filling materials.
• Durability: Materials must have high durability to ensure stability and reliability during use. ISO 1567 and ISO 6872 regulate the durability requirements of metal and ceramic filling materials.
• Ease of use: Materials must be easy to use and convenient for dentists and dental technicians. ISO 10477 regulates the mechanical and chemical performance requirements of composite filling materials.

3. Impression Materials

Dental impression materials are crucial in dentistry, used to create models of teeth and saliva for dental procedures such as restorations, denture casting, dental prosthesis fabrication, etc. To ensure the quality and accuracy of the dental model, impression materials need to meet the following criteria according to international ISO standards:

• Biocompatibility: Materials must be fully evaluated for biological safety, ensuring no harm to the user’s health. ISO 10993 regulates biological evaluation requirements for medical materials, including impression materials.
• Accuracy: Materials must have high accuracy, ensuring the creation of precise and correctly sized dental models. ISO 4823 regulates the accuracy requirements of impression materials.
• Flexibility: Materials must be flexible to easily shape and adhere to teeth, while not causing discomfort to the patient during the impression process. ISO 4823 regulates the flexibility requirements of impression materials.
• Fast Drying: Materials must have a fast and even drying rate, helping to increase the productivity of the impression process. ISO 4823 regulates the drying speed requirements of impression materials.
• Stability: Materials must have high stability, not changing shape or size during transportation and use. ISO 4823 regulates the stability requirements of impression materials.

4. Endodontic Instruments

Endodontic instruments in dentistry include:

• Examination instruments: Specialized mirrors, explorers, periodontal probes, and tweezers.
• Magnification equipment: Using dental microscopes (helps detect enamel cracks in the pulp chamber and roots).
• Isolation instruments (tooth isolation): Rubber dam clamps, rubber dam kits (including clamp forceps, punch, frame, and dam).
• Treatment instruments (non-surgical).
• Length determination devices.
• Access cavity instruments.
• Cleaning and shaping instruments (root canal preparation).
• Irrigation instruments, irrigants, and endodontic medicaments.
• Obturation materials and instruments.
• Core buildup materials.
• Endodontic surgical instruments.

All endodontic instruments in dentistry must ensure standards for:

• Biocompatibility: Ensuring safety for the health of patients and staff at the clinic.
• Hygiene: Endodontic instruments must be manufactured to be easily cleaned and sterilized.
• Durability and Hardness: Endodontic instruments must have sufficient hardness for safe use in examination and treatment according to ISO 17 664.
• Accuracy: Ensuring specific requirements for the accuracy of endodontic instruments according to ISO 7717.
• Aesthetics: Must ensure compliance with ISO 13485 standards.

5. Teeth Whitening Materials

To ensure compliance with international ISO/TC 106 standards, teeth whitening materials in dentistry must meet the following standards:

• Whitening materials must be capable of effective whitening, quickly and safely reducing yellow stains on the tooth surface.
• Whitening materials must ensure user safety and not harm the patient’s teeth or gums.
• Whitening materials must have high stability, not causing changes in tooth color or shape during use.
• Whitening materials must not cause irritation or sensitivity to the patient’s teeth or gums.
• Whitening materials must be compatible with other dental materials, including restorative and filling materials.

6. Disinfectant Materials

All disinfectant materials and chemicals used in dentistry must ensure safety and high efficiency:

• Disinfectant materials and active ingredients must be reliably manufactured, packaged, and transported to ensure product integrity.
• Disinfectant materials and active ingredients must ensure safety for users and not harm patients or medical staff.
• Disinfectant materials and active ingredients must be able to effectively kill bacteria, fungi, and viruses, meeting specific requirements of the corresponding standards.
• Disinfectant materials and active ingredients must have high stability to ensure the effectiveness and safety of the product throughout production, transportation, and use.
• Disinfectant materials and active ingredients must be stored under appropriate conditions to ensure product effectiveness and safety.

7. Medical Consumables

Medical consumables include: gloves & masks (often Latex, Nitrile, Vinyl, or surgical gloves), medical masks. Additionally, there are surgical caps, doctor/nurse uniforms, plastic cups, cotton balls, etc.

All types of medical consumables must fully meet safety and quality standards to protect the health of patients and users.

The import of dental materials must comply with international standards and national medical and commercial legal regulations. The following are some standards to be followed during the dental material import process:

1. Product Quality Standards: Dental materials must be manufactured and inspected to ensure quality consistent with international standards such as ISO, FDA, CE, etc., to ensure patient safety.
2. Medical Standards: Dental materials must be tested to ensure safety for patient health. These materials must be manufactured, transported, stored, and used in a medical environment according to regulations.
3. Transportation Standards: During transportation, dental materials must be carefully packaged and transported correctly to avoid damage and environmental influence from light, temperature, humidity, etc.
4. Customs Standards: Dental materials must be cleared through customs correctly, ensuring full customs documentation and performing customs procedures according to national regulations.
5. Storage Standards: After import, dental materials must be stored and preserved correctly, avoiding exposure to environmental factors like light, temperature, and humidity to ensure product quality.

The following are some of the material production standards in dentistry currently being applied at BeDental:

1. ISO 13485: This standard specifies general requirements for quality management systems for medical products. it includes requirements for the development, design, production, storage, and transportation of medical products.
2. ISO 9001: This standard specifies general requirements for quality management systems for manufacturing companies. It includes requirements for quality management, process management, personnel management, and document management.
3. FDA (U.S. Food and Drug Administration): This agency sets requirements for the safety and effectiveness of medical products before they are allowed access to the U.S. market.
4. CE (Conformite Europeenne): This standard specifies technical and safety requirements for medical products sold in the European Union.
5. ASTM International (American Society for Testing and Materials): This standard provides technical, testing, and quality evaluation standards for materials used in dentistry, including composite, ceramic, metal, and polymer materials.

These standards help ensure that dental products meet requirements for quality, safety, and effectiveness, helping to protect patient health and safety.

Currently, international standards for origin control and quality certification for dental materials are provided by the following world-leading organizations:

1. ISO (International Organization for Standardization) Standards: ISO 13485:2016 is the quality management standard for the production and distribution of medical products, including dental materials. It places particular emphasis on quality management system requirements, including requirements for origin control documentation and quality certification for dental materials.
2. ADA (American Dental Association) Standards: The ADA also has standards for dental materials. This is known as ADA Specification No. 27, and it provides quality requirements and testing standards to ensure safety and efficiency for dental materials.
3. EU MDR (European Union Medical Device Regulation) Standards: EU MDR is a new standard applied since 2021 for all medical products sold in the EU. It requires dental material manufacturers to comply with quality control and safety requirements, including origin control and quality certification documentation.

These international standards provide detailed requirements and guidance on origin control and quality certification for dental materials, ensuring that these materials are safe and meet the necessary quality standards for dental work.