The article provides a brief overview of the applicable regulatory requirements set forth under the existing legal framework.
Table of content
The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of medical devices, has published a guidance document dedicated to air-powered dental handpieces and air motors. In particular, the document describes performance criteria for Safety and Performance Based Pathway.
The document also provides additional clarifications and recommendations to be taken into consideration by the parties involved in order to ensure compliance with the relevant regulatory requirements. At the same time, it is important to mention that provisions of the guidance are non-binding in their legal nature, nor they are intended to introduce new rules or impose new obligations.
Moreover, the authority explicitly states that an alternative approach could be applied, provided such an approach is in line with the underlying legislation and has been agreed with the authority in advance.
Introduction
This document provides performance criteria for air-powered dental handpieces, including contra- and right-angle attachments and air motors, under the FDA’s Safety and Performance-Based Pathway. This framework allows manufacturers submitting a 510(k) to demonstrate substantial equivalence using established performance criteria rather than comparing their devices directly to a predicate device.
It is also mentioned that the applicants/submitters can refer to the FDA Recognized Consensus Standards Database for the current edition of applicable standards. Those declaring conformity to a recognized standard are encouraged to provide appropriate supporting documentation.
Detailed guidance on using consensus standards in regulatory submissions is available in the FDA’s “Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices.”
Regulatory Background
The Safety and Performance-Based Pathway, introduced in September 2019, offers an optional approach for certain device types where FDA-defined performance criteria can demonstrate a device’s safety and effectiveness compared to legally marketed devices. Performance criteria are derived from the expertise of FDA staff, relevant literature, and available data on existing devices, ensuring they meet or exceed the performance of marketed equivalents.
This approach addresses the potential burden associated with direct testing against predicate devices. By relying on established performance benchmarks, the pathway aims to streamline regulatory processes without compromising public health.
For dental handpieces, this less burdensome policy ensures that manufacturers can efficiently demonstrate substantial equivalence while maintaining safety and efficacy standards.
Scope and Device Description
This guidance applies to air-powered dental handpieces and air motors classified as Class I devices under 21 CFR 872.4200 (product codes EFB and EGS). These devices, typically constructed of stainless steel or titanium, are intended for general dentistry purposes such as cutting, grinding, cavity preparation, and crown trimming, with a maximum rotational speed of 450,000 RPM.
Devices covered by this guidance are designed for end-user sterilization and prescription use.
Intended Use and Indications
Air-powered dental handpieces and air motors included in this guidance are for general dentistry and are intended for use by trained professionals.
Devices outside the scope include:
- Non-metallic main bodies.
- Devices incorporating electrical, battery-powered, or software components.
- Handpieces with other power sources, such as water or belt-driven motors.
- Prophy handpieces, single-use devices, or those not intended for user sterilization.
- Handpieces designed for specific purposes, such as bone cutting or ultrasonic scaling.
Device Design Characteristics
Air-powered dental handpieces operate via compressed air, driving a turbine mechanism and facilitating drill rotation. These devices typically feature:
- A head with a chucking mechanism to hold dental files or shanks.
- A straight or angled body connected to an air motor or hose for air and water supply.
- A base with ports for drive air, spray air, and/or water connections.
Air motors convert compressed air into mechanical energy, transferring it to the handpiece for dental procedures. These motors generally include:
- Housing and coupling components for connection to hoses or handpieces.
- Mechanisms for transmitting power to attached handpieces.
Additional Guidance and Case-Specific Considerations
According to the document, manufacturers may refer to the FDA’s general guidance on dental handpieces for further information on submission requirements, including labeling considerations. Additional testing or data may sometimes be necessary to evaluate device eligibility under the Safety and Performance-Based Pathway.
For situations requiring further clarification, manufacturers are encouraged to engage with the FDA through the Q-Submission Program. This allows early discussions to address potential concerns and align expectations before submitting a 510(k).
Conclusion
In summary, the document provides detailed information about the applicable regulatory requirements the products covered by its scope are subject to, highlighting the key aspects to be taken into consideration by the parties involved.
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