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

Device Description

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.

AI/ML Overview

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.

Acceptance Criteria Category	Reported Device Performance (Summary from Text)
Functional Equivalence	The AIR-FLOW MASTER STANDARD's overall design, operating principles (air polisher), cleaning action (projection of air/powder/water mixture), operational unit control, footpedal activation, water/air supply, and powder location are identical or have minor, non-impactful upgrades compared to the predicate AIR-FLOW S2.
Electrical Safety	Electrical safety testing was conducted, and results confirmed the device is safe.
Electromagnetic Compatibility (EMC)	Electromagnetic compatibility testing was conducted, and results confirmed the device is safe.
Biocompatibility	Biocompatibility assessment was conducted, and results confirmed the device is safe.
Functional Testing	Functional testing was conducted, and results confirmed the device is effective for its intended use.
Sterilization Process	AIR-FLOW handpiece and powder nozzle are sterilizable by steam, identical to the predicate device.
Intended Use	The device performs the intended uses for cleaning and polishing teeth and specific cleaning procedures as outlined in Section 5.

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.

Summary

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K073284

510(k) Summary for AIR-FLOW MASTER STANDARD

1. SPONSOR

EMS ELECTRO MEDICAL SYSTEMS SA Ch. de la Vuarpillière 31 CH - 1260 Nyon Switzerland

DEC 1 4 2007

Contact:	Suzanne Fassio-Hardy
Date Prepared:	November 20, 2007

2. DEVICE NAME

Proprietary Name: Common/Usual Name: Classification Name:

AIR-FLOW MASTER STANDARD Airbrush/Dental handpiece Airbrush and accessories/Dental handpiece and accessories

3. PREDICATE DEVICES

. EMS Electro Medical Systems SA, AIR-FLOW S2, K900709

4. DEVICE DESCRIPTION

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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.

5. INTENDED USE

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

6. TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE

The overall design of the proposed AIR-FLOW MASTER STANDARD is identical to the design of the parent AIR-FLOW S2 described in K900709. Both devices include an operational unit, powder chambers, AIR-FLOW handpiece, and the prophylaxis powder. They both contain controls for delivery of the air/water/powder mixture and provide nozzles for delivery. Both of the devices allow for control of the powder/air mixture delivery via a footpedal.

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The technical modifications made to the parent device to produce the AIR-FLOW MASTER STANDARD are limited to removal of the ultrasonic functionality, updating the design of the operating unit, AIR-FLOW handpiece, and powder chambers, and the addition of controlling software. In addition, the prophylaxis powder accessories available were expanded to include the AIR-FLOW Soft prophylaxis powder and expand the offerings in the previously-cleared AIR-FLOW Prophylaxis Powder product line.

The changes made to the parent device to produce the AIR-FLOW MASTER STANDARD are minor and do not represent modifications to the indications for use, operating principles, or the fundamental scientific technology of the device. Testing was conducted to confirm that the proposed AIR-FLOW MASTER STANDARD meets established performance specifications. Based on the above discussion and the comparison chart on the following page, EMS Electro Medical Systems S.A. believes that the proposed AIR-FLOW MASTER STANDARD is substantially equivalent to the parent air-polishing unit, AIR-FLOW S2 cleared for marketing in the U.S. (K900709).

Item for Comparison	AIR-FLOW MASTER STANDARDProposed	AIR-FLOW S2K900709
Intended Use	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, softdeposits, and surface stains from pits, grooves, interproximal spaces, or smoothsurfaces of teeth.
Function	Air polisher	Air polisherUltrasonic scaler
Cleaning and PreparatoryAction	Projection of air/powder/water mixture
Operational Unit	Control of air/powder/water delivery	Same
Footpedal Activation	Yes	Same
Water and Air Supply	External	Same
Powder Location	Powder Chamber	Same
Prophylaxis Powder	AIR-FLOW ClassicAIR-FLOW Soft	AIR-FLOW Prophylaxis powder
Dental Handpiece	AIR-FLOW handpiece*	AIR-FLOW handpiecePiezon handpiece (ultrasonic)
Sterilization Process	AIR-FLOW handpiece and powdernozzle: steam	AIR-FLOW handpiece and powdernozzle: steam

Comparison Chart for Determination of Substantial Equivalence

Minor upgrades from the original handpiece (AIR-FLOW S2); identical to AIR-FLOW Handy2 (K022119)

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7. PERFORMANCE TESTING

The appropriate design verification and design validation activities were conducted to address the potential risks identified in the Risk Analyses for the modifications made to the parent device, AIR-FLOW S2. These activities included electrical safety testing, electromagnetic compatibility testing, biocompatibility assessment, and functional testing. The results confirmed that the AIR-FLOW MASTER STANDARD is safe and effective for its intended use.

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 4 2007

(EMS SA) Electro Medical Systems C/O Ms. Susan M. Bonapace Regulatory Associate Medical Device Consultants, Incorporated 49 Plain Street North Attleboro, Massachusetts 02760

Re: K073284

Trade/Device Name: AIR-FLOW MASTER STANDARD Regulation Number: 872.6080 Regulation Name: Airbrush Regulatory Class: II Product Code: EFB, KOJ Dated: November 20, 2007 Received: November 21, 2007

Dear Ms. Bonapace:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Ms. Bonapace

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Spon Ruano
C. Chia-Lin, Ph.D.

Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known):

AIR-FLOW MASTER STANDARD Device Name:

Indications for Use:

The AIR-FLOW MASTER STANDARD is an air-polishing unit intended for use in The AINS LOW MA Creeth by the projection of water, air, and dental the cleaning and polisions
powders onto the tooth surface. The device removes dental plaque, soft deposits, powders onto the took.
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 .

Over-The-Counter Use AND/OR Prescription Use × (21 CFR 807 Subpart C) (Part 21 CFR 801 Subpart D)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Kanner

Regulation Number and Section

§ 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.