Toxicological Elements of Dentistry - Hazards, Safety and Dental Devices: Dental Materials and Devices

What is Biocompatibility?

Biocompatibility refers to the ability of a material to interact with living tissue without causing adverse effects. Key adverse effects caused by bio-incompatible materials are:

• Cytotoxicity – toxicity of materials or devices to cells and cellular growth.
• Sensitization – allergic reaction potential to materials or devices.
• Genotoxicity – toxicity of materials or devices to DNA
• Systemic toxicity – effects on the whole body or specific body system caused by materials or devices.

Resources:

• FDA Industry Guidance on ISO 10993-1 biological evaluation of medical devices
• FDA Biocompatibility Assessment Resource Center
• Chemva: Chemical Characterization and Toxicological Risk Assessment: How Can They Address Biocompatibility Evaluations for Medical Devices?

 

Testing Biocompatibility

eBooks:

Biocompatibility Testing of Medical Devices
Offers practical guidance for medical device evaluation under ISO 10993, including case studies and testing strategies.

Biocompatibility and Performance of Medical Devices
Explores how biocompatibility impacts safety and regulatory compliance, with updates on testing methodologies.

ISO Standards:

Print copies of ISO Standards for biocompatibility testing are available from the Holman Biotech Commons, and can be requested for pickup from the Dental Medicine Library using the links below. Commonly cited testing standards are below, but all ISO 10993 standards are focused on testing substances for biological safety. See the list of all testing standards here.

• ISO 10993-1: Evaluation and testing within a risk management process
• ISO 10993-3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
• ISO 10993-5: Tests for in vitro cytotoxicity
• ISO 10993-10: Tests for irritation and skin sensitization
• ISO 10993-11: Tests for systemic toxicity

FDA Approval Pathways

The FDA's Center for Devices and Radiological Health (CDRH) regulates dental materials and devices based on the level of risk they pose. Medical and dental devices are classified into three categories:

Key Resources:

• FDA Dental Devices Portal: Central FDA page with guidance documents and regulatory information specific to dental devices.
• FDA Device Classification Guide: Helps determine the classification and regulatory pathway of your dental device based on its risk level.
• 510(k) Submission Guide: Official guide to submitting a premarket notification to demonstrate substantial equivalence of a device to a legally marketed one.
• FDA Product Classification Database: Look up existing medical devices by class. Determine if newly developed devices have substantial equivalence to an existing marketed device.

The American Dental Association has partnered with Forsyth to create the ADA Forsyth Professional Dental Products Certification Program. Starting in early 2026 newly developed dental products and materials will be able to be certified by this program for safety and efficacy.

Learn more about the program on the ADA website here.