BOSWORTH AIR POLISHER

K100731 · Harry J. Bosworth Co. · EFB · Dec 3, 2010 · Dental

Device Facts

• Record ID: K100731
• Device Name: BOSWORTH AIR POLISHER
• Applicant: Harry J. Bosworth Co.
• Product Code: EFB · Dental
• Decision Date: Dec 3, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4200
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

This device is a dental handpiece that is intended for tooth cleaning and polishing by the use of a powder, water, and air spray stream onto the tooth surface. The Bosworth Air Polisher is a dental handpiece used for cleaning and polishing teeth. It projects a spray of water, air, and powder onto the tooth surface. The Bosworth air Polisher is designed to be used by a Dental Professional.It is a prescription device The packaging contains the following statement. "Caution: Federal law restricts this device to sale by or on the order of a Dentist. "

Device Story

Hand-held dental air polisher; connects to standard dental operatory turbine tube for air/water supply. Device features integrated powder chamber and nozzle. Operator activates via foot pedal to generate spray of air, water, and dental powder. Directed at tooth surfaces to remove plaque, soft deposits, and stains. Used in dental clinics by dental professionals. Benefits patient through mechanical cleaning of tooth surfaces. Device tested for 130-treatment reuse life and turbine connection integrity at 47-53 psi.

Clinical Evidence

Bench testing only. Testing included verification of 130-treatment reuse life (15 hours) and turbine tube connection integrity at 47-53 psi.

Technological Characteristics

Hand-held dental handpiece; air/water/powder spray delivery. Components: powder chamber, nozzle, turbine tube adapter. Sterilization: steam. Connectivity: pneumatic connection to dental operatory unit. No software or electronic components.

Indications for Use

Indicated for cleaning and polishing teeth, including removal of dental plaque, soft deposits, and surface stains from pits, grooves, interproximal spaces, or smooth surfaces. Intended for use by dental professionals on prescription.

Regulatory Classification

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.

Predicate Devices

• AirFlow Master Standard (K073284)

Submission Summary (Full Text)

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Attachment B

K100731

510(k) Summary for

Bosworth-Air-Polisher_

## Sponsor

Harry J. Bosworth Company 7227 N. Hamlin Avenue Skokie, Illinois 60076-0399 USA

DEC - 3 2010

Establishment # 1410638

Contact Person: Gary Chuven Telephone: [phone] ext. 240

Date Prepared: 10 November 2010

Device Name

Proprietary Name: Common/Usual Name: Classification name: Regulation: Product code:

Bosworth Air Polisher Dental handpiece Dental handpiece and accessories 21 CFR 872.4200 EFB

#### Device Description

The Air Polisher is a hand-held device that contains air and water lines, a capped chamber for the cleaning powder, and a nozzle. This device connects to a standard turbine tube that supplies air and water. When the Air Polisher is connected and activated, a stream comprised of powder, air, and water spray is generated. This spray can be directed on the tooth surface to clean and polish the tooth.

#### Intended Use

This device is a dental handpiece that is intended for tooth cleaning and polishing by the use of a powder, water, and air spray stream onto the tooth surface.

### Technological Characteristics and Substantial Equivalence

The Bosworth Air Polisher and the predicate device AirFlow Master Standard (Electro Medical Systems K073284) are used for cleaning and polishing of teeth.

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Both the Bosworth Air Polisher and the predicate device have an identical operating principle. Projection of a powder, water, and air spray stream onto the tooth-surface-provides-the-cleaning-and-polishing-action______________________________________________________________________________________________________________________

| Comparison Item | Bosworth Prophy Gun -<br>Proposed | EMS Air-Flow Master<br>Standard - K073284 |
|----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------|
| Intended Use | Cleaning & polishing of teeth by the projection of water, air, & dental powder onto the tooth surface. The device removes dental plaque, soft deposits, and surface stains from pits, grooves, interproximal spaces, or smooth surfaces of teeth. | Air Polisher |
| Function | Air Polisher | Air Polisher |
| Cleaning &<br>Preparatory Action | Projection of air/water/powder mixture. | Projection of air/water/powder mixture. |
| Delivery Control | Dental operatory unit | Dedicated operational unit |
| Foot pedal Activation | Yes | Same |
| Water & Air Supply | External | Same |
| Powder Location | Powder chamber on the handpiece | Powder chamber on the operational unit |
| Prophy Powder | Bosworth Prophy Powder | Air-Flow Classic |
| Sterilization Process | Handpiece & powder nozzle: steam | Handpiece & powder nozzle: steam |

# Comparison Chart for Determination of Substantial Equivalence

# Performance Testing

The Bosworth Air Polisher was tested to support a minimal reuse life of 130 treatments, which corresponds to 15 hours of use. The Turbine tube connection was tested for integrity to demonstrate that the connection between the Bosworth Air Polisher and the turbine adapter, when subjected to air pressures of 47 - 53 psi, remained intact.

# Conclusion Statement

Based on the comparison between the Bosworth Air Polisher and the predicate device AirFlow Master Standard, the clinical information, and on the specific testing performed on the Bosworth Air Polisher, we conclude that the Bosworth Air Polisher is substantially equivalent to the predicate device.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three tail feathers, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the eagle. The eagle is black, and the text is also black.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Mr. Gary Chuven Quality & Regulatory Manager Harry J. Bosworth Company 7227 North Hamlin Avenue Skokie, Illinois 60076

Re: K100731

Trade/Device Name: Bosworth Air Polisher Regulation Number: 21 CFR 872.4200 Regulation Name: Dental Handpiece and Accessories Regulatory Class: I Product Code: EFB Dated: November 15, 2010 Received: November 17, 2010

DEC - 3 2010

Dear Mr. Chuven:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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- Mr. Chuven

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely vours.

Wh for

Anthony D. Watson, B.S., M.S., M.B.A. 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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510(K) Number: K100731

Device Name: Bosworth Air Polisher

# INDICATIONS FOR USE:

The Bosworth Air Polisher is a dental handpiece used for cleaning and polishing teeth. It projects a spray of water, air, and powder onto the tooth surface. The Bosworth air Polisher is designed to be used by a Dental Professional.It is a prescription device The packaging contains the following statement. "Caution: Federal law restricts this device to sale by or on the order of a Dentist. "

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

OR Over-the-Counter Use
Su(Optional Format 1/2/96)

(Division Sign-Off) (Division Sign-Oit)
Division of Anesthesiology, General Hospital
Division of Anesthesiology, General Devices Division of Ansothol. Dental Devices

510(k) Number: