USFDA's Center for Devices and Radiological Health has released four final guidances about dental products, such as Dental Impression Materials, Dental Ceramics, Dental Cements and Air Powered Dental Handpieces and Air Motors.
Guidance: Dental Impression Materials - Performance Criteria for Safety and Performance-Based Pathway
This guidance outlines the necessary safety and performance criteria for manufacturers to bring dental impression materials to the market through the FDA’s Safety and Performance Based Pathway, which relies on demonstrating that a new device meets specific performance criteria rather than requiring direct clinical testing for each new product. This guidance applies to dental impression materials, including alginates, elastomeric materials, and polyether materials used in creating molds of patients' teeth for the production of dental appliances.
This guidance provides performance criteria and safety benchmarks for dental ceramic materials used in restorative dental procedures. These materials are critical for fabricating crowns, bridges, veneers, and other restorations. This guidance applies to dental ceramics, including materials such as porcelain, zirconia, and other ceramic-based materials used in dental prosthetics. The recommendations are intended to promote consistency and facilitate efficient review of dental ceramics.
Dental cements are essential for bonding dental prosthetics like crowns, bridges, inlays, and onlays to natural tooth structures or implants, and their performance is critical to the success and durability of these restorations. This guidance applies to dental cements used in both temporary and permanent dental restorations. The primary focus is on ensuring that dental cements meet specific performance criteria related to their safety and effectiveness in clinical use.
Guidance: Air Powered Dental Handpieces and Air Motors - Performance Criteria for Safety and Performance-Based Pathway
This Guidance establishes the performance standards and safety requirements for air-powered dental handpieces and air motors, ensuring these devices meet the necessary criteria for their use in clinical dental procedures. This guidance applies to air-powered dental handpieces and air motors used by dental professionals for a variety of procedures, including cutting, shaping, and polishing teeth or dental materials. These tools must meet performance criteria that ensure they are safe for both the patient and the operator, and that they function effectively under the conditions typically encountered in dental practice.
Also, check out this guidance about "Clarification of Radiation Control Regulations For Manufacturers of Diagnostic X-Ray Equipment" which addresses the requirements that apply to diagnostic x-ray equipment under the electronic product provisions of the FD&C Act and the regulations implementing those provisions.
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