HHC PUSH-BUTTON REPLACEMENT TURBINE FOR MIDWEST TRADITION HANDPIECE MODEL MW TURBINE REPLACEMENT

K100389 · Handpiece Headquarters · EFB · Aug 12, 2010 · Dental

Device Facts

• Record ID: K100389
• Device Name: HHC PUSH-BUTTON REPLACEMENT TURBINE FOR MIDWEST TRADITION HANDPIECE MODEL MW TURBINE REPLACEMENT
• Applicant: Handpiece Headquarters
• Product Code: EFB · Dental
• Decision Date: Aug 12, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4200
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

This HHC-Push button air turbine is intended for use with the Midwest Tradition Handpiece in replacement of Midwest Tradition's original turbine. The Dental Handpiece with the HHC- replacement turbine is used by authorized persons in the practice of dentistry. The HHC-replacement turbine is used in the Midwest Tradition High Speed Dental Handpiece, which is intended for removing carious material, cavity preparations, finishing tooth preparations, reducing hard tooth structures, restorations and polishing teeth.

Device Story

HHC-Push button air turbine is a replacement turbine for Midwest Tradition high-speed dental handpieces. Device operates via high-pressure air (35 psi) impacting impeller blade pockets, driving rotation at minimum 420,000 rpm. Cooling water (2 bar) is delivered via inlet tube to the cutting area. Used by dentists/authorized personnel in clinical settings for tooth preparation and restoration. Output is mechanical rotation of a dental bur. Benefits include restoration of handpiece function using a compatible replacement component.

Clinical Evidence

Bench testing only; no clinical data required. Performance testing confirmed the device functioned as intended with results comparable to the predicate device.

Technological Characteristics

Materials: 440C stainless steel (spindle, bearings), aluminum (impeller), Buna (O-ring). Operation: Air-powered turbine, 35 psi, 420,000 rpm min. Chuck: Push-button auto chuck. Dimensions: 0.125" OD, 0.425" length. Conformance: Meets ISO standard for shanks (0.0625"-0.0630").

Indications for Use

Indicated for use by dental professionals in the Midwest Tradition High Speed Dental Handpiece for removing carious material, cavity preparation, finishing tooth preparations, reducing hard tooth structures, restorations, and polishing teeth.

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

• NSK- Replacement Turbine for Midwest Tradition Handpiece (K971774)

Submission Summary (Full Text)

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K100389

**Handpiece**
Headquarters

AUG 2 2010

34

A HENRY SCHEIN® COMPANY

## 510(K) SUMMARY:

HHC- push button replacement turbine for Midwest Tradition.

210K

a- Submitted by:

HANDPIECE HEADQUARTERS 620 S. Placentia Ave. Placentia, CA 92870 Tel. [phone] Fax. [phone]

b- Contact person: ·

Tina Steffanie-Oak Tel. [phone], ext. 4150 Fax. [phone] [e-mail] Email:

c- Date summary prepared:

Revised 06-10-10

d- Device Name:

HHC- push button replacement turbine for Midwest Tradition Trade or Proprietary Name:

Common Name: Classification Name: Air-Power Dental Handpiece Dental Handpiece and accessories (21CFR 872.4200) Class: I

Product Code:

EFB "Handpiece, Air-powered, Dental"

e- Substantial Equivalency is claimed against the following device:

NSK- Replacement Turbine for Midwest Tradition Handpiece Products of NSK NAKANISHI INC. (K971774)

f- Description of the device:

The HHC-Push button air turbine is a complete air turbine which will be offered as replacement turbine for Midwest Tradition original turbine.

High pressured air directly impacts the blade pockets of the impeller through an air intake tube located inside the handpiece body, which causes the air turbine to rotate at a high speed. The dental cutting bur connects to the turbine's shank (spindle),

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which rotates at the same speed as the impeller. Cooling water flows through an inlet water tube at high pressure and blows out at an angle near the dental cutting bur to reduce temperature at cutting area.

#### g- Statement of Intended Use:

This HHC-Push button air turbine is intended to use with Midwest Tradition Handpiece in replacement of Midwest Tradition's original turbine.

The Midwest Tradition Handpiece with the replacement turbine is used by authorized persons in the practice of dentistry.

The replacement turbine is used in the Midwest Tradition High Speed Dental Handpiece, which is intended for removing carious material, cavity preparations, finishing tooth preparations, reducing hard tooth structures, restorations and polishing teeth.

### h- Safety and effectiveness of the device:

The HHC-Push button air turbine is as safe and effective as the predicate device as cited above.

#### 1 - Device and Predicate Comparison Table:

| Descriptive Information | Subject Device: HHC-Midwest<br>Tradition Replacement Turbine | Predicate: NSK-Midwest Tradition<br>Replacement Turbine |
|-------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indication of use | This HHC-Push button air turbine is<br>intended to use in Midwest Tradition<br>Handpiece in replacement of Midwest<br>Tradition's original turbine.<br><br>The Dental Handpiece with the<br>replacement turbine is used by<br>authorized persons in the practice of<br>dentistry.<br><br>This replacement turbine used in<br>Midwest Tradition Handpiece is<br>intended for removing carious material,<br>cavity preparations, finishing tooth<br>preparations, reducing hard tooth<br>structures, restorations and polishing<br>teeth: | The devices claimed herein are the air turbines<br>only, not the handpiece itself.<br>The devices are intended for use in the<br>Midwest's Quiet-air or Tradition handpieces, in<br>place of Midwest's original turbines.<br><br>The device, therefore, is, with Midwest<br>handpiece, intended for use in general dental<br>applications, such as cutting a tooth for crown<br>preparation, cavity preparation, finishing the<br>crown, inlay or the filling, etc. |
| Device Design: | | |
| Operation mode | Intake air pressure 35 psi- speed<br>420,000 rpm. Min. | Intake air pressure 35 psi- speed 420,000 rpm<br>Min. |
| Air/water ports | N/A | N/A |
| Fiber Optics | N/A | N/A |
| Type of chuck | Push button chuck (auto chuck) | Push button chuck(auto chuck) |

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| Coupling dimensions | n/a | n/a |
|---------------------------------|----------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------|
| Accessories | n/a | n/a |
| Composition of material | | |
| Spindle | 440C stainless steel (see more details in attachment 4 material table) | Stainless steel |
| Impeller | Aluminum (see more details in attachment 4 material table) | Aluminum |
| Bearings | 440C stainless steel. (see more details in attachment 4 material table) | Stainless steel |
| O-ring | Buna (see more details in attachment 4 material table) | Buna |
| Technical specification | | |
| Chuck | Push button chuck spindle<br>Outside diameter: 0.125"<br>Chuck length: 0.425"<br>Actuator height: 0.034" | Push Button:<br>Outside diameter: 0.125"<br>Chuck length: 0.435"<br>Actuator height: 0.038" |
| Light intensity | n/a | n/a |
| Bur extraction force | 5 lbs Min. push and pull forces/ 100 inspection using ONMI gauge/ per specification indicated on drawing | 5 lbs Min. push and pull forces- tested on predicate device |
| Air pressure | 35 psi. recommended | 35 psi. |
| Water pressure | 2 bar | 2 bar |
| Speed Rpm | 420,000 rpm. Min. | 420,000 rpm. Min. |
| Hose connection | n/a | n/a |
| Conformance standard for shanks | Meet I.S.O standard Shank diameter from 0.0625" to 0.0630" | Meet I.S.O standard shank |
| Lubricant | n/a | Dental lubricated oil |
| | | Lubricant recommended but specific type and it is not indicated in labeling. |

### J - Performance Data:

The HHC-Push button air turbine performance tests were carried out to evaluate it In all instances the HHC-Push button air turbine against the predicate device. functioned as intended, results observed were as expected, and was determined to have comparable performance and safety as compared to the predicate.

No clinical data was required.

#### K -Conclusion:

Based on the information in the notification Handpiece Headquarters believes that this HHC-Push button air turbine is substantially equivalent to the claimed predicate device. (NSK- Replacement Turbine for Midwest Tradition Handpiece Products of NSK-NAKANISHI INC. (K971774))

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Image /page/3/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 lines representing its wings and legs. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

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

Ms. Tina Steffanie-Oak Senior Regulatory Specialist Handpiece Headquarters 620 S. Placentia Avenue Placentia, California 92870

AUG 1, 2 2010

Re: K100389

Trade/Device Name: HHC- push button replacement turbine for Midwest Tradition Regulation Number: 21 CFR 872.4200 Regulation Name: Dental Handpiece and Accessories Regulatory Class: II Product Code: EFB Dated: August 6, 2010 Received: August 6, 2010

Dear Ms. Steffanie-Oak:

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 preemarket approval application (PMA). You may, therefore, market the device, subject to the emeral 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 - Ms. Steffanie-Oak

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. 10, 10, 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/ResourcesforYou/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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# Indications for Use

AUG 1 2 2010

510(k) Number (if known): Kloo389

Device Name: HHC- push button replacement turbine for Midwest Tradition

Indications for Use:

This HHC-Push button air turbine is intended for use with the Midwest Tradition Handpiece in replacement of Midwest Tradition's original turbine.

The Dental Handpiece with the HHC- replacement turbine is used by authorized persons in the practice of dentistry.

The HHC-replacement turbine is used in the Midwest Tradition High Speed Dental Handpiece, which is intended for removing carious material, cavity preparations, finishing tooth preparations, reducing hard tooth structures, restorations and polishing teeth.

Prescription Use .X AND/OR (Per 21 CFR 801 Subpart D) Subpart C)

Over-The-Counter Use

(Per 21 CFR 801

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Loe Miley for MSP Page 1 of 1
(Division Sign-Off)

Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number:

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