AIR TORX, MODEL TRA-200, TRA-200-CP3, TRA-200-CP4

K091065 · J. Morita USA, Inc. · EFB · Oct 16, 2009 · Dental

Device Facts

• Record ID: K091065
• Device Name: AIR TORX, MODEL TRA-200, TRA-200-CP3, TRA-200-CP4
• Applicant: J. Morita USA, Inc.
• Product Code: EFB · Dental
• Decision Date: Oct 16, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4200
• Device Class: Class 1

Intended Use

AIR TORX is used as a motor to drive attachments by air supplied from the treatment unit's air supply system. Attachments are geared handpieces that are used to drill and polish teeth.

Device Story

AIR TORX is an air-powered dental handpiece motor; operates by receiving air from a dental treatment unit's supply system; drives geared attachments used for grinding, drilling, and polishing teeth. Used by dental professionals in clinical settings. Device functions as a mechanical power source for dental instruments; output is rotational motion delivered to attachments. Benefits include facilitating standard dental procedures.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Air-powered dental handpiece motor; pneumatic energy source; mechanical drive for attachments. No electrical components. Design and performance characteristics are similar to existing dental handpiece motors.

Indications for Use

Indicated for use as a motor to drive dental attachments for drilling and polishing teeth in a dental clinical setting.

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

• MICRO AIR MOTOR A-25LT (K944713)

Submission Summary (Full Text)

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#### 510(k) SUMMARY

K091065

# J. MORITA USA Inc.'s AIR TORX Type: TRA-200, TRA-200-CP3, TRA-200-CP4

### 1. NAME OF DEVICE

OCT 1 6 2009 AIR TORX Trade or Proprietary Name: Type: TRA-200, TRA-200-CP3, TRA-200-CP4 Handpiece, Air-powered, Dental Common Name:

# 2. SUBMITTER NAME AND ADDRESS WITH PHONE/FAX

| Registration No. 2081055<br>Initial Distributor:<br>J. Morita USA, Inc.<br>9 Mason<br>Irvine, CA 92618<br>USA<br>Telephone: [phone]<br>Facsimile: 949-581-9688 | Registration No. 3002807636<br>Manufacturer:<br>J. MORITA MFG. CORP.<br>680 Higashihama Minami-cho<br>Fushimi-ku, Kyoto<br>Japan 612-8533<br>[phone]<br>[phone] |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

## 3. CONTACT PERSON

Keith A. Barritt Fish & Richardson P.C. 1425 K Street, N.W. Suite 1100 Washington, DC 20005 Phone: [phone] Facsimile: [phone]

#### 4. DATE SUMMARY PREPARED: April 8, 2009

## 5. DEVICE CLASSIFICATION/CLASSIFICATION PANEL

The Air Torx has been classified as non-exempt Class I devices. Device classification: 21CFR 872.4200 Dental handpiece and accessories

Device classification panel:

872 Dental Devices

84

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#### 6. DEVICE DESCRIPTION/SUBSTANTIAL EQUIVALENCE

#### DEVICE DESCRIPTION

This instrument is designed for dental treatment such as grinding, drilling and polishing teeth.

#### SUBSTANTIAL EQUIVALENCE

Comparison summary table with predicate device is as follows. AIR TORX and its predicate device has similar general intended uses, similar principles of operation, and similar technological characteristics. Although there are minor differences in the characteristics of the AIR TORX and its predicate devices, these differences do not raise new questions of safety or effectiveness.

#### Comparison summary table

Name and 510(k) number of predicate device: MICRO AIR MOTOR A-25LT, K944713

| Technological characteristics | Comparison result |
|--------------------------------------------------|-------------------|
| Indication for use | Similar |
| Target population | Similar |
| Design | Similar |
| Materials | Unknown |
| Performance | Similar |
| Sterility | Similar |
| Biocompatibility | Unknown |
| Mechanical safety | Similar |
| Chemical safety | Similar |
| Anatomical sites | Similar |
| Human factors | Similar |
| Energy used and/or delivered | Similar |
| Compatibility with environment and other devices | Similar |
| Where used | Similar |
| Standards met | Unknown |
| Electrical safety | N/A |
| Thermal safety | Unknown |

### 7. INDICATIONS FOR USE

AIR TORX is used as a motor to drive attachments by air supplied from the treatment unit's air supply system.

Attachments are geared handpieces that are used to drill and polish teeth.

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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 depiction of an eagle or bird with outstretched wings. The bird is positioned to the right of a circular border containing the text "DEPARTMENT OF HEALTH & HUMAN SERVICES U.S.A."

#### Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

# NOV 18 2009

J. Morita USA, Incorporated C/O Mr. Keith A. Barritt Fish & Richardson P.C. 1425 K Street, Northwest, Suite 1100 Washington, DC 20005

Rc: K091065 Trade/Device Name: AIR TORX Regulation Number: 21 CFR 872.4200 Regulation Name: Dental Handpiece and Accessories Regulatory Class: I Product Code: EFB Dated: September 30, 2009 Received: October 1, 2009

Dear Mr. Barritt:

This letter corrects our substantially equivalent letter of October 16, 2009.

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 (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 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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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 contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. 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 contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.

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/cdrh/industry/support/index.html.

Sincerely yours,

Wh for

Susan Runner, D.D.S., M.A. Acting Division 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):

091065

Device Name:

AIR TORX

. Indications For Use:

AIR TORX is used as a motor to drive attachments by air supplied from the treatment unit's air supply system.

Attachments are geared handpieces that are used to drill and polish teeth.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR ·

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Kein Muly fa MSR
(Division Sign-Off)

Division of Anesthesiology, General Hospital Infection Control, Dental Devices

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510(k) Number: K091065