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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.

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The AIR-FLOW MASTER STANDARD is an air-polishing unit intended for use in the cleaning and polishing of teeth by the projection of water, air, and dental powders onto the tooth surface. The device removes dental plaque, soft deposits, and surface stains from pits, grooves, interproximal spaces, or smooth surfaces of teeth.

The device can also be used for the following cleaning procedures:

• plaque removal for placement of sealants
• surface preparation prior to bonding/cementation of inlays, onlays, crowns and veneers
• surface preparation prior to placing composite restorations
• effective plaque and stain removal for orthodontic patients
• cleaning prior to bonding ortho brackets
• cleaning implant fixture prior to loading
• stain removal for shade determination
• plaque removal prior to fluoride treatment
• plaque and stain removal prior to whitening procedure

The AIR-FLOW MASTER STANDARD is an air-polishing unit containing an operating unit, air/water pressure powered handpiece cords, powder chambers, AIR-FLOW handpieces, prophylaxis powders, multifunction footpedal and connections for external water and air supply. The operating unit of the AIR-FLOW MASTER STANDARD regulates the water and air/powder flow and selection of the prophylaxis powder chamber (Working Mode). The multifunction footpedal controls the operation of the AIR-FLOW handpieces. Upon installation, the AIR-FLOW MASTER STANDARD operating unit is connected to the external water and air supply.

Prior to use, the prophylaxis powder is loaded into the powder chamber and the chamber fixed to the operating unit. The AIR-FLOW handpiece is inserted into the air pressure powered handpiece cord and a powder nozzle is attached to the end of the AIR-FLOW handpiece. The operating unit is switched on and the air/powder flow and the Working Mode are adjusted on the control panel. When the operating unit is switched on, the powder chambers are under pressure. Air enters the powder chamber of the operating unit where it mixes with the prophylaxis powder. The air/powder mixture leaves the powder chamber and enters the handpiece cord. When the multifunction footpedal is pressed, the air pressure of the handpiece cord is activated and allows the air/powder mixture to be delivered to the AIR-FLOW handpiece for treatment. The air/powder mixture exits the distal end of the AIR-FLOW handpiece through the powder nozzle where it is enveloped by a water spray and directed onto the tooth surface.

This 510(k) summary describes a dental device, the AIR-FLOW MASTER STANDARD, which is an air-polishing unit. The submission aims to demonstrate substantial equivalence to a previously cleared device, the AIR-FLOW S2 (K900709). The information provided does not include a comparative study with a detailed breakdown of acceptance criteria and device performance in the way a clinical trial or AI device study would. Instead, it focuses on demonstrating that modifications to a predicate device do not alter its fundamental safety and effectiveness.

Here's an analysis based on the provided text, addressing the requested points where possible, and noting where information is not present in this type of submission:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not present specific quantitative acceptance criteria or detailed in-vitro/in-vivo performance data in a table format for the device's cleaning and polishing efficacy. Instead, the "acceptance criteria" are implied by successful completion of various engineering and safety tests, and the performance is assumed to be substantially equivalent to the predicate device.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: Not specified in the document. The testing mentioned (electrical safety, EMC, biocompatibility, functional testing) typically involves engineering samples of the device itself rather than a clinical "test set" of patients or data, as this is a physical device and not an AI/software product requiring patient data for performance evaluation in the same way.
• Data Provenance: Not applicable in the context of patient data. The provenance of the engineering and safety tests would be the testing laboratories, likely in the country of manufacture (Switzerland for EMS Electro Medical Systems SA). The testing is prospective for the new device.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This information is not applicable and not provided. The "ground truth" for a physical device like an air-polisher is its ability to perform its function (e.g., deliver air, water, and powder effectively, maintain safety standards). Experts involved would be engineers, safety specialists, and biocompatibility experts, not typically a panel establishing "ground truth" in the way a medical image interpretation study would.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies, particularly for subjective assessments or when independent expert review is needed for ground truth establishment (e.g., reading medical images). For physical device testing, the criteria are objective, and the results are typically directly measured and compared against specifications.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No. An MRMC study is not relevant for this type of physical dental device. MRMC studies are typically employed for diagnostic devices and algorithms, often involving human readers (e.g., radiologists, pathologists) interpreting medical images or data, with and without AI assistance, to assess the impact of the AI on human performance.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

No. This is a physical device, an air-polishing unit, not a software algorithm. Therefore, "standalone" algorithm performance is not a concept applicable to this submission. While it mentions "controlling software," this software controls the physical operation of the device, not performs a diagnostic or analytical function independently of human operation.

7. The Type of Ground Truth Used

The "ground truth" for this device is derived from:

• Engineering Specifications: The device must meet predefined specifications for air/water pressure, powder delivery, power consumption, etc.
• Safety Standards: Compliance with electrical safety, EMC, and biocompatibility standards.
• Functional Performance: Demonstration that the device effectively performs its mechanical functions as intended (e.g., mixing and delivering the air/powder/water mixture).
• Predicate Device Equivalence: The ultimate "ground truth" for this 510(k) is that it is substantially equivalent to a legally marketed predicate device that has already been deemed safe and effective. The burden is to show the new device meets the same performance and safety expectations as the predicate.

8. The Sample Size for the Training Set

Not applicable. This is not a machine learning or AI algorithm in the context of needing a "training set" of data to learn from. The "training" for such a device involves product design, development, and engineering, which are not based on data sets in this way.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no "training set" in the context of AI/ML algorithms. The design and engineering process for a physical device involves meeting established engineering principles, safety standards, and performance specifications through iterative design and testing.

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