Technical Standards: Biomaterials Used in Dentistry
Regulatory references and best practices for the use, storage, and traceability of dental biomaterials
Introduction
Biomaterials used in dentistry are medical devices employed in regenerative and reconstructive procedures, such as bone grafts, guided tissue regeneration, implantology, periodontology, and oral and maxillofacial surgery.
Because they are implantable or remain in direct contact with human tissues, their use is subject to sanitary, technical, and ethical requirements designed to ensure patient safety, clinical efficacy, and product traceability.
In addition to the regulations of the National Health Surveillance Agency (ANVISA), it is essential to strictly follow the Manufacturer's Instructions for Use (IFU), which establish conditions for storage, transport, handling, sterility, validity, and indications for use.
Understanding these standards is crucial to ensure the conformity of dental procedures, reduce care risks, and guarantee that biomaterials maintain their safety and performance characteristics throughout their entire usage cycle.
Why do standards exist for Biomaterials?
Biomaterials remain in direct contact with living tissues and often become an integral part of the bone or tissue regeneration process. Any failure related to storage, handling, or use can compromise the clinical outcome and increase risks to the patient.
The main objectives of technical standards are:
- To ensure patient safety during surgical procedures.
- To guarantee the use of biomaterials regulated by ANVISA.
- To preserve the sterility and integrity of products until their use.
- To standardize storage, transport, and handling processes.
- To ensure the traceability of implanted biomaterials.
- To reduce risks of contamination, adverse events, and therapeutic failures.
- To promote compliance with health legislation and professional ethics.
These regulations also serve as a reference for sanitary inspections, audits, quality programs, and accreditation processes in dental clinics and services.
Main standards and regulations
| Standard | Application | Objective |
|---|---|---|
| ANVISA RDC No. 848/2024 | Medical devices | Defines the essential safety and performance requirements applicable to medical devices, including dental biomaterials. |
| Regularization of medical devices with ANVISA | Biomaterials | Establishes criteria for product registration, notification, manufacturing, import, and commercialization. |
| Code of Dental Ethics (CFO) | Professional practice | Defines the ethical responsibility of the dental surgeon regarding the use of safe, indicated, and scientifically recognized materials. |
| IFU – Manufacturer's Instructions for Use | All biomaterials | Determines storage conditions, clinical indication, handling, contraindications, and shelf life. |
Standards by environment
Dental Offices
Main references: ANVISA RDC No. 848/2024 • Code of Dental Ethics • IFU
Ensure that only regularized biomaterials are used, respecting storage conditions, validity, and traceability.
Dental Clinics
Main references: ANVISA RDC No. 848/2024 • IFU • Internal protocols
Standardize the receipt, storage, inventory control, batch verification, and documentation of biomaterials.
Dental Surgical Centers
Main references: ANVISA RDC No. 848/2024 • IFU
Ensure aseptic handling, verification of sterile packaging integrity, and complete recording of implanted materials.
Educational Institutions
Main references: ANVISA RDC No. 848/2024 • IFU • Institutional protocols
Ensure that practical activities exclusively use regularized biomaterials stored according to manufacturer specifications.
Related SOPs
Standard Operating Procedures (SOPs) typically cover:
- Receipt and inspection of biomaterials.
- Verification of packaging integrity.
- Batch and expiration date control.
- Storage according to IFU.
- Temperature control where applicable.
- Aseptic handling during procedures.
- Traceability record in the patient chart.
- Disposal of expired, damaged, or unusable products.
- Recording of non-conformities.
Required documentation
- Product registration or sanitary regularization, where applicable.
- Manufacturer's Instructions for Use (IFU).
- Batch and validity control.
- Invoice or acquisition documentation.
- Record of biomaterial used in the patient's chart.
- SOPs related to storage and use.
- Team training records, where applicable.
Storage and Preservation
Proper storage is essential to preserve the safety, sterility, and performance of dental biomaterials.
Most bone grafts, synthetic biomaterials, tissue regeneration membranes, and alloplastic materials available on the market are stored at controlled room temperature, typically between 15 °C and 30 °C, as specified by the manufacturer.
Some biomaterials containing specific biological components or bioactive factors may require refrigeration or other special storage conditions. In these cases, the guidelines in the Instructions for Use (IFU) must be strictly observed.
Good storage practices include:
- keeping products in their original packaging;
- protecting against moisture, excessive heat, and direct light, where applicable;
- respecting the temperature range indicated by the manufacturer;
- storing in a clean, dry, and organized place;
- controlling batch and validity;
- not using opened or damaged packaging.
ANVISA RDC No. 848/2024 establishes that transport and storage must not compromise the safety, performance, and sterility of the medical device, and the conditions specified by the manufacturer must be observed throughout the product's life cycle.
Products that aid in compliance
- Regularized biomaterials.
- Membranes for tissue regeneration.
- Bone grafts.
- Synthetic biomaterials (alloplastics).
- Instruments for implantology and surgery.
- Sterile surgical kits.
- Surgical drapes.
- Suture materials.
- PPE.
- Biosafety products.
- Batch identification and traceability systems.
Frequently Asked Questions
Does every biomaterial need to be regularized with ANVISA?
Biomaterials subject to sanitary regularization must meet the requirements established by ANVISA before their commercialization and clinical use.
Do all biomaterials need to be refrigerated?
No. Most dental biomaterials are stored at controlled room temperature, generally between 15 °C and 30 °C. However, some products may require refrigeration or specific storage conditions. The Manufacturer's Instructions for Use (IFU) should always take precedence.
Should the biomaterial batch be recorded in the patient chart?
Yes. Recording the batch, manufacturer, and validity is part of good traceability practices and contributes to patient safety.
Can I use a biomaterial with a compromised package?
No. Products with damaged, compromised, or non-sterile packaging should not be used.
Are the Manufacturer's Instructions for Use (IFU) mandatory?
Yes. IFUs establish the conditions for storage, handling, clinical indication, contraindications, and other requirements necessary for the safe use of the biomaterial.
Who is responsible for the correct use of biomaterials?
It is the dental surgeon's responsibility to select appropriate biomaterials, verify their regularization, follow the manufacturer's guidelines, and maintain documentation and traceability of the products used.
Conclusion
Compliance with technical standards related to biomaterials is essential to ensure safety, clinical predictability, and regulatory conformity in dental procedures. In addition to using regularized products, proper storage, adherence to the Manufacturer's Instructions for Use (IFU), batch control, and traceability are fundamental pillars of good care practices.
By adopting standardized protocols and keeping technical documentation updated, clinics, offices, and educational institutions strengthen the quality of services provided, reduce health risks, and contribute to safer, more ethical dentistry aligned with current legal requirements.
