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.

2. Dental Filling Materials

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

ISO 10993 Standard

This is the international standard used to evaluate the biological safety of medical materials, including those in dentistry. This standard evaluates factors such as material integrity, biocompatibility, toxicity, irritation, and the potential to cause allergic reactions.

1. Chemical and Physical Properties: Evaluating chemical and physical properties of materials to determine their impact on the body.
2. Biological Properties: Evaluating the impact of materials on cells, tissues, the immune system, and the nervous system.
3. Interaction: Evaluating the interaction of materials with blood and other biological fluids.
4. Integrity: Ensuring materials do not cause adverse effects during production, transportation, and use.
5. Stability: Ensuring materials do not decompose or change properties in the oral environment.
6. Toxicity: Materials do not cause serious side effects for users.

ANSI/ADA Standards

The American Dental Association (ADA) standards specify requirements for durability, chemical stability, corrosion resistance, and safety when used in the oral environment.

1. Corrosion Resistance: Resisting corrosion and oxidation in environments with changing pH levels.
2. Compatibility: Not causing irritation to soft tissues and the oral environment.
3. Color Stability: Maintaining color throughout the period of use.
4. Mechanical Durability: Meeting requirements for long-term use.
5. Health Safety: Not posing a danger to patients.

FDA Standards

Materials are inspected according to the regulations of the U.S. Food and Drug Administration (FDA), ensuring:

1. Safety: Proven safe for use in the oral cavity.
2. Durability and Efficiency: Ensuring strength and corrosion resistance.
3. Non-allergenic: Minimizing the risk of irritation.
4. Easy to manipulate: Convenient for the treatment process.

CE Standard (European)

Materials achieving CE certification meet the strict requirements of the European Union regarding safety, efficiency, and quality control.

1. Safety: Does not pose a hazard to the user’s health.
2. Effectiveness: Ensures performance for dental applications.
3. Compatibility: Fits the oral environment and other materials.
4. Non-allergenic: Limits side effects.
5. Quality Control: Stable and consistent production across batches.

The disinfection system at BeDental is controlled according to strict international standards to ensure absolute sterility during the treatment process:

ISO 17664:2017 – Regulates the cleaning, disinfection, and sterilization processes for medical devices.

ASTM E2197-17 – Evaluates the effectiveness of disinfectant products in killing bacteria, fungi, and viruses.

EN 13060:2014 – European standard for the performance and safety of sterilization equipment.

FDA 510(k) – Requires medical devices and products to be proven safe and effective before being put into use.

• Non-allergenic: Materials must not cause allergic reactions or irritation to the user.
• Ease of use: Materials must be easy to use and convenient for dental procedures, including mixing and handling capabilities.
• Quality Control: Materials must be manufactured and quality-controlled to ensure stability and consistency across different production batches.
• Recyclability: Materials should ideally be recyclable or biodegradable to minimize environmental impact.