In alignment with this framework, the FDA has issued guidance enabling certain dental products to be evaluated based on predefined performance criteria. This approach allows manufacturers to demonstrate substantial equivalence using established benchmarks rather than directly comparing the performance of the subject device to a predicate device.

The FDA’s guidance applies to the following dental products and regulations:

1. Endosseous Dental Implants and Abutments

• Endosseous dental implant (DZE) - 21 CFR 872.3640,
• Endosseous dental implant abutment (NHA) - 21 CFR 872.3630
• These devices are surgically placed in the bone of the upper or lower jaw to support prosthetic devices such as artificial teeth, restoring the patient’s chewing function.

2. Air-Powered Dental Handpieces and Air Motors

• Dental air powered handpieces and air motors (EFB) - 21 CFR 872.4200
• Contra- and right-angle attachment (EGS) - 21 CFR 872.4200
• These prescription-use devices are utilized by trained dental professionals for various procedures, including the removal of carious material, cavity and crown preparation, impacted molar extraction, and periodontal surgeries.

3. Dental Impression Materials

• Dental Impression Materials (ELW) - 21 CFR 872.3660
• These materials are designed to be placed on a preformed impression tray and used to replicate the structure of a patient’s teeth and gums.

4. Dental Cements

• Dental cement (EMA) - 21 CFR 872.3275
• Resin tooth bonding agent (KLE) -21 CFR 872.3200
• Bracket adhesive resin and tooth conditioner (DYH) -21 CFR 872.3750
• These products serve multiple purposes, such as temporary tooth fillings, base cements for securing dental devices like crowns, bridges, and orthodontic brackets, and as a protective layer for tooth pulp to enhance the retention of restorations.

5. Dental Ceramics

• Porcelain powder for clinical use (EIH) - 21 CFR 872.6660
• Porcelain tooth (ELL) - 21CFR 872.3920
• These materials, composed of a mixture of kaolin, feldspar, quartz, and other substances, are used in the production of artificial teeth, jacket crowns, facings, bridges, and veneers for both fixed and removable dentures.

This guidance provides manufacturers with a streamlined pathway for demonstrating compliance while ensuring device safety and performance.

Conclusion:

The FDA’s Safety and Performance-Based Pathway is a step forward in simplifying the device clearance process without compromising safety or quality. By focusing on clear performance standards, it makes it easier for manufacturers to bring innovative dental products—like implants, handpieces, and dental cements—to market faster. This approach not only reduces regulatory hurdles but also ensures that patients continue to have access to safe and effective tools for dental care.

 

 

References:

1. Endosseous Dental Implant Abutments - Performance Criteria for Safety and Performance Based Pathway
2. Air Powered Dental Handpieces and Air Motors – Performance Criteria for Safety and Performance Based Pathway
3. Dental Impression Materials –Performance Criteria for Safety andPerformance Based Pathway
4. Dental Cements – Performance Criteria for Safety and Performance Based Pathway
5. Dental Ceramics – Performance Criteria for Safety and Performance Based Pathway