The ProSmile Air Polisher is intended for removing deposits, plaque, and staining on all visible tooth surfaces as well as in fissures and interdental areas. The ProSmile is also intended for the following prophylactic applications:

cleaning teeth prior to scaling
cleaning teeth prior to fluoridation
cleaning teeth prior to bleaching
cleaning teeth prior to using bonding materials .

Device Description

The ProSmile consists of the handpiece, ProSmile Prophylaxis Powder, the powder jet nozzle, test card, and hose coupling. The components that are integral to the C8+ Dental Operative Unit and used during ProSmile operation are the powder chamber. powder chamber venting button, water regulator, air/powder regulator, and foot control. The ProSmile is a pneumatically operated device that is offered with two powder jet nozzles.

AI/ML Overview

The provided text describes a 510(k) submission for the Sirona Dental Systems ProSmile Air Polisher and Prophylaxis Powder. It outlines the device's intended use, description, and basis for substantial equivalence to a predicate device.

However, the document does not contain specific acceptance criteria or a detailed study proving the device meets performance criteria beyond a general statement about functional testing and risk analysis.

Therefore, I cannot provide the requested information in the format specified because the necessary details are not present in the given text.

Here's why and what information is available:

Missing Information:

Specific Acceptance Criteria: The document does not list quantitative or qualitative acceptance criteria for the device's performance (e.g., a specific percentage of plaque removal, a certain level of stain reduction, or a maximum abrasion level).
Detailed Study Data: While it states "Functional testing" was conducted and "results confirmed that the ProSmile is safe and effective," no details of this functional testing are provided. This includes:
- Reported Device Performance: No specific metrics or results are given.
- Sample Size: No information on the number of subjects, teeth, or procedures used in any test.
- Data Provenance: No mention of the origin of data (e.g., clinical trials, in-vitro experiments, country of origin).
- Experts for Ground Truth: No mention of experts, their qualifications, or their role in establishing ground truth.
- Adjudication Method: Not applicable as there's no expert assessment described.
- MRMC Comparative Effectiveness Study: No such study is mentioned. The comparison is primarily structural and functional similarity to a predicate device.
- Standalone Performance: No specific standalone performance metrics are provided.
- Type of Ground Truth: Not described as there's no detailed study.
- Training Set Sample Size: No training set is mentioned, as this appears to be a device performance evaluation (design verification/validation), not an AI/algorithm-based diagnostic device.
- Ground Truth for Training Set: Not applicable.

Information Present (but not directly answering the full request):

Intended Use: Removing deposits, plaque, and staining, and for prophylactic applications (cleaning prior to scaling, fluoridation, bleaching, bonding).
Basis for Substantial Equivalence: Visual and operational similarity to the EMS Air Flow Handy 2 Air Polisher and Powder (K022119). Both use a mixture of water, air, and powder for dental cleaning.
Performance Testing Mentioned: "The appropriate design verification and design validation activities were conducted to address the potential risks identified in the Hazard Analysis. These activities included electrical safety testing, electromagnetic compatibility testing, and functional testing. The results confirmed that the ProSmile is safe and effective for its intended use." This is a high-level summary without any specifics.

In summary, the provided document is a 510(k) summary focused on demonstrating substantial equivalence to a predicate device through general design and safety testing, rather than a detailed clinical or performance study report with specific acceptance criteria and detailed performance metrics.

Summary

{0}------------------------------------------------

11033675

JAN 1 5 2004

510(k) Summary

for

Sirona Dental Systems ProSmile Air Polisher and Prophylaxis Powder

1. SPONSOR

Sirona Dental Systems GmbH Farbrikstrasse 31 64625 Bensheim Germany

Contact Person: Fritz Kolle Regulatory Manager

Date Prepared: November 21, 2003

2. Device Name

Proprietary Name:	ProSmile Air Polisher and Prophylaxis Powder
Common/Usual Name:	Air Polisher, Abrasive Polishing Agent
Classification Name:	Air Brush

3. Predicate Devices

EMS Air Flow Handy 2 Air Polisher and Powder, K022119

4. INTENDED USE

. cleaning teeth prior to scaling
. cleaning teeth prior to fluoridation
. cleaning teeth prior to bleaching
cleaning teeth prior to using bonding materials .

{1}------------------------------------------------

5. DEVICE DESCRIPTION

6. BASIS FOR SUBSTANTIAL EQUIVALENCE

Both the ProSmile and EMS Air Flow Handy 2 devices are polishers intended for removing plaque deposits and stains using a mixture of water, air, and powder in dental cleaning procedures. The overall design of the proposed device is similar to that of the predicate device. Both include a dental handpiece and powder accessory, controls for delivery of the air/water/powder mixture, and delivery nozzles. Both devices allow for control of the /powder/air from the foot control. The proposed device differs from the predicate device in that the powder container for the ProSmile is located in the C8+ dentist's element, while the powder container for the predicate device is located in the device handpiece.

7. PERFORMANCE TESTING

The appropriate design verification and design validation activities were conducted to address the potential risks identified in the Hazard Analysis. These activities included electrical safety testing, electromagnetic compatibility testing, and functional testing. The results confirmed that the ProSmile is safe and effective for its intended use.

{2}------------------------------------------------

Image /page/2/Picture/11 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular emblem with the department's name encircling an abstract symbol. The symbol resembles a stylized caduceus, featuring three parallel lines that curve and converge, representing the health aspect of the department. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 1 5 2004

Sirona Dental Systems GmbH C/O Ms. Mary McNamara-Cullinane, RAC Staff Consultant Medical Device Consultants, Incorporated 49 Plain Street North Attleboro, Massachusetts 02760

Re: K033675

Trade/Device Name: Prosmile Air Polisher and Prophylaxis Powder Regulation Number: 21 CFR 872.6080 Regulation Name: Airbrush Regulatory Class: II Product Code: KOJ Dated: November 21, 2003 Received: November 24, 2003

Dear Ms. McNamara-Cullinane:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave feviewed your Bocken - 1 (c) per device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce use stated in the energoure) to regard date of the Medical Device Amendments, or to devices that provision with the may and chance 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 thereone, mailket the detired, backed in annual registration, listing of devices, good Controls provisions of the revile, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your de nee to such additional controls. Existing major regulations affecting your device can be Illay 06 subject to such additions. Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

{3}------------------------------------------------

Page 2 - Ms. Mary McNamara-Cullinane

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 (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 may be obtained 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/dsma/dsmamain.html

Sincerely yours.

Chiu S. Lin, PhD

Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

K033675 510(k) Number (if known):

ProSmile Air Polisher and Prophylaxis Powder Device Name:

Indications for Use:

cleaning teeth prior to sealing .
cleaning teeth prior to fluoridation .
cleaning teeth prior to bleaching .
cleaning teeth prior to using bonding materials .

(PI.F.ASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NECESSARY)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Runser

(Division Sign-Off) Division of Anesthesiology, General Hospital, ection Control Denta

510(k) Number: K033275

Prescription Use
(Per 21 CFR 801.109) √

Over-The-Counter Use

(Optional Format 1-2-96)

Sirona Dental Systems GmbH 510(k) ProSmile Air Polisher and Prophylaxis Powder

November 21, 2003

Regulation Number and Section

§ 872.6080 Airbrush.

(a)
Identification. An airbrush is an AC-powered device intended for use in conjunction with articulation paper. The device uses air-driven particles to roughen the surfaces of dental restorations. Uneven areas of the restorations are then identified by use of articulation paper.(b)
Classification. Class II. The special control for this device is International Electrotechnical Commission's IEC 60601-1-AM2 (1995-03), Amendment 2, “Medical Electrical Equipment—Part 1: General Requirements for Safety.”