(246 days)
The AIR-FLOW handy 3.0 Dental Handpiece is a dental handpiece intended for use in the cleaning and polishing of teeth by the projection of a mixture of water, air, and EMS prophylaxis powder onto the tooth surface. The device removes soft deposits and areas of discoloration and can be used to prepare teeth for dental procedures such as the placement of composite fillings, porcelain inlays, and laminate veneers. The device can be used to clean implant abutments and to clean teeth prior to treatments such as shade matching, fluoridation, and bleaching. The device can also be used to degrease crowns and bridges prior to placement and clean fixed bands and brackets on orthodontic appliances.
The proposed AIR-FLOW handy 3.0 is a modification of the AIR-FLOW handy 2 Dental Handpiece previously cleared under K022119. This device modification has been submitted as a Special 510(k) Premarket Notification because the indications for use for the proposed AIR-FLOW handy 3.0 are identical to the parent AIR-FLOW handy 2. The fundamental technology and design of the proposed AIR-FLOW handy 3.0 are essentially identical to the AIR-FLOW handy 2 dental handpiece.
Both the proposed AIR-FLOW handy 3.0 and the predicate AIR-FLOW handy 2 connect to a standard turbine connection on a dental operative unit and deliver a mixture of water, air, and dental powder to a treatment site.
Modifications made to the AIR-FLOW handy 2 Dental Handpiece to produce the AIR-FLOW handy 3.0 were limited to minor design changes to enhance the ergonomics of the design, including:
- Location of the powder chamber is modified to improve the visibility of the mouth of patient by the practitioner during the treatment.
- Slimmer shape of the powder chamber to be in-line with the body of the device to improve the visibility of the mouth of patient by the practitioner during the treatment.
- Diameter of the powder chamber cap is reduced to be in-line with new design of the powder chamber.
- The powder chamber capacity has been slightly decreased to 21g from 23g to fit new ergonomic design.
- The body of the handy 3.0 is made of 2 glued molded part instead of 1 molded part.
- The handpiece is shorter and slimmer to improve ergonomics.
Accessories were included to aid in filling the powder chamber and removing residual powder from the handpiece channels.
In addition, the AIR-FLOW CLASSIC COMFORT prophylaxis powder has been added to the panel of available prophylaxis powders. The chemical composition of the AIR-FLOW CLASSIC COMFORT Powder is identical to the AIR-FLOW CLASSIC that was described in the 510(k) Premarket Notification for the AIR-FLOW MASTER (K073284). The grain size was slightly reduced from a median particle size of
This document describes the AIR-FLOW handy 3.0 dental handpiece. The submission for this device is a Special 510(k) Premarket Notification, indicating that it is a modification of a previously cleared device (AIR-FLOW handy 2, K022119) and shares the same indications for use, fundamental technology, and design. Therefore, the device proves substantial equivalence to its predicate device rather than meeting specific quantifiable performance criteria as would be required for a novel device.
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1. Table of Acceptance Criteria and Reported Device Performance
As this is a Special 510(k) based on substantial equivalence to a predicate device due to minor modifications (ergonomics, slightly reduced powder chamber capacity, and a new powder with smaller grain size for comfort), there are no specific quantifiable acceptance criteria for device performance in terms of metrics like sensitivity, specificity, accuracy, or other clinical outcomes.
The "acceptance criteria" here are implicitly that the modified device performs at least as well as the predicate device for its intended use, and that the modifications do not introduce new questions of safety or effectiveness.
| Acceptance Criteria (Implied for Substantial Equivalence) | Reported Device Performance |
|---|---|
| Maintain the same intended use as the predicate device (AIR-FLOW handy 2, K022119). | The indications for use for the AIR-FLOW handy 3.0 are identical to the parent AIR-FLOW handy 2. The device is intended for use in the cleaning and polishing of teeth by the projection of a mixture of water, air, and EMS prophylaxis powder onto the tooth surface. It removes soft deposits and discoloration, prepares teeth for dental procedures (composite fillings, porcelain inlays, laminate veneers), cleans implant abutments, prepares teeth for shade matching, fluoridation, and bleaching, degreases crowns and bridges, and cleans fixed bands and brackets on orthodontic appliances. |
| Maintain fundamental technology and design essentially identical to the predicate device. | The fundamental technology and design of the AIR-FLOW handy 3.0 are essentially identical to the AIR-FLOW handy 2. Both connect to a standard turbine connection and deliver a mixture of water, air, and dental powder. Modifications were limited to minor design changes to enhance ergonomics (powder chamber location, slimmer shape, reduced cap diameter, slightly decreased powder chamber capacity, two glued molded parts instead of one, shorter and slimmer handpiece). |
| Non-clinical performance demonstrates fulfillment of prospectively defined performance specifications. | Non-clinical performance testing demonstrates that the AIR-FLOW handy 3.0 fulfills the prospectively defined performance specifications. (Specific details of these specifications are not provided in this summary but are implicit for the device type). |
| Modifications (including new powder) do not negatively impact safety or effectiveness. | The new AIR-FLOW CLASSIC COMFORT prophylaxis powder has an identical chemical composition to the predicate's AIR-FLOW CLASSIC powder; its grain size was slightly reduced ( |
§ 872.4200 Dental handpiece and accessories.
(a)
Identification. A dental handpiece and accessories is an AC-powered, water-powered, air-powered, or belt-driven, hand-held device that may include a foot controller for regulation of speed and direction of rotation or a contra-angle attachment for difficult to reach areas intended to prepare dental cavities for restorations, such as fillings, and for cleaning teeth.(b)
Classification. Class I.