TWIN POWER TURBINE HIGH SPEED AIR TURBINE DENTAL HANDPIECE

K043498 · J. Morita USA, Inc. · EFB · Feb 16, 2005 · Dental

Device Facts

• Record ID: K043498
• Device Name: TWIN POWER TURBINE HIGH SPEED AIR TURBINE DENTAL HANDPIECE
• Applicant: J. Morita USA, Inc.
• Product Code: EFB · Dental
• Decision Date: Feb 16, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4200
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

TWIN POWER TUBINE is for use by authorized persons in the practice of the dentistry.

Device Story

Air-powered dental handpiece; utilizes air turbine for high-speed rotation; requires connection to dental unit for air, cooling water, and light source; cooling water delivered via pouring holes for cutting treatment; used in dental clinics by dentists/authorized personnel; provides mechanical cutting/drilling capability for dental procedures; benefits patient by enabling precise tooth structure removal/restoration.

Clinical Evidence

No clinical data; substantial equivalence based on bench testing and comparison of technological characteristics.

Technological Characteristics

Air-powered turbine; includes variations for light (LED/fiber optic) and head assembly (standard, torque-up, miniature); connects to dental unit via 4-hole coupling or ISO9168 tube connections; materials and design similar to predicate; non-electronic mechanical device.

Indications for Use

Indicated for use by authorized dental professionals for dental procedures.

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

• Synea-HS High-Speed Handpiece (K992011)

Submission Summary (Full Text)

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#### 0434 ું જ

## FEB 1 6 2005

#### 510(k) SUMMARY

### J. MORITA MFG. CORP.'s TWIN POWER TURBINE 4H/DI

#### 1. Submitter Name and Address with Phone/Fax :

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

#### 2. Contact Person

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

September 29, 2004 3. Date summary prepared:

#### 4. Device Name:

| Trade or Proprietary Name: | TWIN POWER TURBINE PAR series<br>PAR-4H series<br>(PAR-4HE/ PAR-4HE-O/ PAR-4HS/ PAR-4HS-O)<br>PAR-DI series<br>(PAR-E-DI/ PARE-O-DI/ PAR-S-DI/ PAR-S-O-DI<br>PAR-M-DI/ PAR-M-O-DI) |
|----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name: | Air powered dental handpiece |
| Classification Name: | Dental handpiece and accessories<br>(21CFR 872.4200 ) |
| Product Code : | EFB ( "Handpiece, Air-powered, Dental " ) |

- 5. Substantial Equivalency is claimed against the following device: Synea-HS High-Speed Handpiece from A-Dec, Incorporated ( K992011) .
:

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#### 6. Description of the device:

#### VII-1 DEVICE DESCRIPTION

#### TWIN POWER TURBINE is a dental handpiece

This device receives energy resources in handpiece such as air for high speed air turbine, cooling water for cutting and light source for illumination, through the tubes connected to a dental unit.

The cooling water is fed part of cutting treatment through pouring holes.

TWIN POWER TURBINE is classified into the model as is shown below Table-1 from the variations of light and motor.

| (-: not included ) | | | | | | |
|--------------------------------|------------|----------------|----------|------------------|----------------------------|-------------------------------|
| Name | Model | Main Body | | Coupling | | |
| | | Body | Light | Head<br>assembly | 4-hole<br>coupling | Tube<br>connection<br>ISO9168 |
| TWIN<br>POWER<br>TURVINE<br>4H | PAR-4HE | PAR-4HE | - | Standard | CP-4,<br>CP4-A or CP4-W | Type-B |
| | PAR-4HE-O | PAR-<br>4HE-O | Included | Standard | CP4-O,<br>CP4-AO or CP4-WO | Type-C |
| | PAR-4HS | PAR-4HS | - | Torque-up | CP-4,<br>CP4-A or CP4-W | Type-B |
| PAR-<br>4Hseries | PAR-4HS-O | PAR-<br>4HS-O | Included | Torque-up | CP4-O,<br>CP4-AO or CP4-WO | Type-C |
| TWIN<br>POWER<br>TURVINE<br>P | PAR-E DI | PAR-E<br>DI | - | Standard | - | - |
| | PAR-E-O DI | PAR-E-O<br>DI | Included | Standard | - | - |
| PAR-<br>Diseries | PAR-S DI | PAR-S DI | - | Torque-up | - | - |
| | PAR-S-O DI | PAR-S-O<br>DI | Included | Torque-up | - | - |
| | PAR-M DI | PAR-M<br>DI | - | Miniature | - | - |
| | PAR-M-O DI | PAR-M-<br>O DI | Included | Miniature | - | - |

Models of PAR series Table-1

2/3

And Children Children

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#### 7. Intended Use

TWIN POWER TUBINE is for use by authorized persons in the practice of the dentistry.

#### Safety and effectiveness of the device 8.

This device is safe and effective as the other predicate device cited above. This is better expressed in the tabulated comparison as below.

### Substantial Equivalent comparison summary table

| The predicate device and its 510k number: | |
|-----------------------------------------------------------------|-------------------|
| Synea-HS High-Speed Handpiece from A-Dec, Incorporated K992011 | |
| Attachment inside notification submission file | |
| The promotional materials of its predicate device, Attachment 3 | |
| TECHNOLOGICAL<br>CHARACTERISTICS | Comparison result |
| Indication for use | Identical |
| Target population | Identical |
| Design | Similar |
| Materials | Similar |
| Performance | Similar |
| Sterility | Similar |
| Biocompatibility | Similar |
| Mechanical safety | Similar |
| Chemical safety | Similar |
| Anatomical sites | Similar |
| Human factors | Similar |
| Energy used and/or delivered | Similar |
| Compatibility with environment<br>and other devices | Similar |
| Where used | Identical |
| Standards met | Similar |
| Electrical safety | Similar |
| Thermal safety | Not applicable |
| Radiation safety | Not applicable |

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circle with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle. Inside the circle is an abstract symbol that resembles a stylized caduceus, which is a symbol often associated with healthcare. The symbol is composed of three curved lines that converge at the bottom.

Public Health Service

FEB 1 6 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

J. Morita USA, Incorporated C/O Mr. Keith A. Barritt Fish & Richardson P.C. 1425 K Street, N.W. 11" Floor Washington, DC 20005

Re: K043498

Trade/Device Name: Twin Power Turbine High Speed Air Turbine Dental Handpiece Regulation Number: 872.4200 Regulation Name: Dental Handpiece and Accessories Regulatory Class: I Product Code: EFB Dated: December 16, 2004 Reccived: December 17, 2004

Dear. Mr. Barritt:

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 cither class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting vour 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. Barritt

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 (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.

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- . 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Greta Michie Davis

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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# 498

# Indications for Use

510(k) Number (if known): K#043498

TWIN POWER TURBINE high speed air turbine dental handpiece Device Name: Indications For Use:

The TWIN POWER TURBINE handpiece is for use by authorized persons in the practice of dentistry,

Prescription Use x (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)

Susan Purge

on Skin-Off) tion of Anesthesiology. General Hospital, con Control, Dental Devices

Number K043498

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