AirLight Dental Handpiece
FDA 510(k)EUDAMEDClass I (US FDA 510(k))
Identifiers
- 510(k) Number
- K112623 FDA 510(k)
- FDA Product Code
- EFB FDA 510(k)
Classification
- Device Class
- Class I FDA 510(k)
- Legislation / Framework
- 21 CFR Part 872.4200 FDA 510(k)
- Regulation Number
- 872.4200 FDA 510(k)
- Advisory Committee
- Dental FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The AirLight Dental Handpiece is an air-powered dental handpiece, classified as a Handpiece, Air-Powered, Dental under regulatory nomenclature. It is designed for high-speed dental procedures, delivering precise rotary motion for cutting, shaping, and polishing teeth and restorative materials in clinical settings. The device operates using compressed air to drive its turbine mechanism, enabling efficient and controlled dental work.
This handpiece is supplied as a reusable medical device, intended for use in dental offices and clinics. It is not sterile upon delivery but is designed for repeated use with appropriate cleaning, sterilization, and maintenance protocols. The device is FDA-cleared under 510(k) and complies with MDD and MDR regulations. No specific MRI safety classification is indicated, and sizes or variants are referenced by model numbers (e.g., M800) in the product line.
Frequently asked questions
Is the AirLight Dental Handpiece intended for single-use or can it be reused in a clinical setting?
The AirLight Dental Handpiece is designed for reusable use in dental offices and clinics. Since it is not sterile upon delivery, it must undergo cleaning, sterilization, and maintenance between patient encounters to ensure safety and functionality. The manufacturer provides protocols for proper reprocessing to support its repeated use.
What models or variants of the AirLight Dental Handpiece are available, and how do they differ?
The AirLight Dental Handpiece is available in multiple model variants, such as the M800, though specific differences between models (e.g., speed, torque, or ergonomic features) are not detailed in the provided data. Model numbers likely correspond to variations in performance or design, but exact specifications would require consulting the manufacturer’s technical documentation or product line guide.
How is the AirLight Dental Handpiece powered, and what clinical procedures is it primarily used for?
The AirLight Dental Handpiece is air-powered, using compressed air to drive its turbine mechanism for precise rotary motion. It is primarily designed for high-speed dental procedures, including cutting, shaping, and polishing teeth and restorative materials. This makes it suitable for tasks like cavity preparation, crown and bridge work, and general tooth restoration.
What regulatory pathways has the AirLight Dental Handpiece followed, and what does this mean for its use?
The AirLight Dental Handpiece has undergone FDA 510(k) clearance, as well as compliance with the Medical Device Directive (MDD) and Medical Device Regulation (MDR). This indicates it has met regulatory standards for safety and performance in the U.S. and EU markets, respectively. The FDA’s Traditional 510(k) pathway confirms it is deemed *substantially equivalent* to a predicate device, ensuring its design and functionality align with established dental handpiece standards.
Does the AirLight Dental Handpiece have any specific storage requirements, and is it compatible with MRI environments?
The provided data does not specify storage requirements for the AirLight Dental Handpiece, but reusable medical devices typically require protection from moisture, dust, and extreme temperatures. As for MRI compatibility, the data does not indicate an MRI safety classification, meaning its use in MRI environments should be evaluated carefully—either by consulting the manufacturer or ensuring it does not contain metallic components that could interfere with imaging or pose safety risks.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Beyes Dental Handpiece and Equipment, AirLight | Beyes Dental Canada, | DPS, Airlight_Brochure - Beyes Dental Canada - PDF Catalogs | Technical ..., Airlight® M800 High-Speed Surgical Handpiece, BEYES AIRLIGHT HIGHSPEED HANDPIECE SERIES OPERATOR'S ... - ManualsLib
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
MDD
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Active |
| EUDAMED | European Union | MDD | — | Class I | Active |
| FDA 510(k) | United States | FDA_510K | K112623 | Class I | Active |
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Manufacturer
- Manufacturer
- Beyes Dental Canada Inc
- FDA Applicant
- Beyes Dental Canada, Inc.
Sources (2)
- FDA 510(k) K112623 24 fields · synced Sep 20, 2026
- EUDAMED 1 fields · synced May 19, 2026