TORQTECH

K103697 · J. Morita USA, Inc. · EGS · Jan 20, 2012 · Dental

Device Facts

• Record ID: K103697
• Device Name: TORQTECH
• Applicant: J. Morita USA, Inc.
• Product Code: EGS · Dental
• Decision Date: Jan 20, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4200
• Device Class: Class 1

Intended Use

TORQTECH transmits rotation of the motor to dental burrs and reamers which cut or grind teeth or dentures with the same or transformed rotation.

Device Story

TORQTECH is a dental handpiece designed for polishing, grinding, and drilling teeth or dentures. The device attaches to an electric or air-powered dental motor; it transmits rotational force from the motor through a clutch to a rotor shaft. Dental burrs or reamers are chucked onto the shaft to perform clinical procedures. Available in straight (ST-DH) and angled/geared (CA-DC, CA-DC-O, CA-51F-O) models; geared models vary by angle and rotation. An optional headlight is available, powered via a light-guide from the motor. Used in dental clinics by dentists or dental professionals. The device provides mechanical rotation to dental instruments, enabling precise tooth or denture modification. Includes an LS spray for lubrication, containing fatty acid ester, mineral oil, and propellants (propane, butane, isobutane).

Clinical Evidence

No clinical tests were performed. Evidence consists of bench testing and compliance with international standards, including ISO 7785-2 (handpiece performance), ISO 14971 (risk management), and ISO 10993 (biocompatibility/cytotoxicity/sensitization/irritation for the lubricant spray).

Technological Characteristics

Mechanical dental handpiece; straight and geared angle configurations. Materials evaluated per ISO 10993-1. Standards met: ISO 7785-2 (handpiece performance), ISO 3964 (coupling dimensions), ISO 14971 (risk management), ISO 17664 (reprocessing), EN 980/1041 (labeling). Energy source: external electric or air-powered dental motor. Includes optional light-guide. Lubricant spray contains fatty acid ester, mineral oil, and hydrocarbon propellants (propane, butane, isobutane).

Indications for Use

Indicated for dental professionals to perform cutting, grinding, or polishing of teeth or dentures using dental burrs or reamers attached to an electric or air-powered motor.

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

• INTRAmatic, INTRAcompact, and GENTLEpower (K080677)
• Twinpower Turbine handpiece (K061701)
• AR Spray (K070074)
• KAVO QUATTROcare spray (K012308)

Submission Summary (Full Text)

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K103697

JAN 2 0 2012

# 510(k) SUMMARY

J. MORITA USA Inc.'s TORQTECH: Type: ST-DH, CA-DC, CA-DC-O, and CA-51F-O K#103697

#### l. NAME OF DEVICE

Trade or Proprietary Name: TORQTECH Type: ST-DH, CA-DC, CA-DC-O, CA-51F-O Common Name: Dental handpiece and accessories

### 2. SUBMITTER NAME AND ADDRESS WITH PHONE/FAX

Registration No. 2081055 Initial Distributor: J. Morita USA, Inc. 9 Mason Irvine, CA 92618 USA Telephone: [phone] Facsimile: 949-581-9688

Registration No. 3002807636 Manufacturer J. MORITA MFG. CORP. 680 Higashihama Minami-cho Fushimi-ku, Kyoto Japan 612-8533 [phone] [phone]

#### 3. CONTACT PERSON

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

### 4. DATE SUMMARY PREPARED: December 5, 2010

### DEVICE CLASSIFICATION/CLASSIFICATION PANEL ડ.

The TORQTECH has been classified as non-exempt Class 1 devices. Device classification: 21CFR 872.4200 Dental handpiece and accessories 872 Dental Devices

Device classification panel:

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### 6. DEVICE DESCRIPTION/SUBSTANTIAL EQUIVALENCE

# DEVICE DESCRIPTION

The TORQTECH device is a dental handpiece to be attached to an electric or air powered dental motor, designed for polishing, grinding, and drilling of teeth/dentures. The device transmits rotational force from the motor to the rotor shaft through a clutch, and the dental burrs or reamers chucked on the shaft are able to polish, grind or cut the teeth/dentures of the patient receiving these rotations.

There are two types of the TORQTECH device: one is a "straight" linear model (Model ST-DH) while the other is angled and geared (Models CA-DC, CA-DC-O, and CA-5IF-O). The geared models vary based on angle and rotation due to the gear between the clutch and rotor shaft. An optional headlight is available, fed through the light-guide from the motor portion.

# SUBSTANTIAL EQUIVALENCE

The TORQTECH and its predicate devices have similar general intended uses, similar principles of operation, and similar technological characteristics. Although there are minor differences in the characteristics of the TORQTECH and its predicate devices, these differences do not raise new questions of safety or. effectiveness.

The TORQTECH is substantially equivalent to the following devices:

(1) Kaltenbach & Voight GmbH's "INTRAmatic," "INTRAcompact," and "GENTLEpower" (K#080677) for purposes of performance characteristics; and

(2) J. Morita Manufacturing Corp.'s own "Twinpower Turbine" handpiece (K#061701) for purposes of biocompatibility of materials

(3) J. Morita Manufacturing Corp.'s own "AR Spray" (included as part of K#070074) and KAVO "KavoQuattrocare" spray (K#012308) for purposes of the LS Spray that is included with the TORQTECH device.

Two charts identifying the specific characteristics of these various devices appear below:

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| Technological Characteristics of Handpiece | Comparison result | |
|--------------------------------------------------|-------------------|-----------|
| | K080677 | K061701 |
| Indication for use | Similar | - |
| Target population | Identical | - |
| Design | Similar | - |
| Materials | Unknown | Identical |
| Performance | Similar | - |
| Sterility | Similar | Similar |
| Biocompatibility | Unknown | Identical |
| Mechanical safety | Similar | - |
| Chemical safety | Similar | Identical |
| Anatomical sites | Similar | - |
| Human factors | Similar | - |
| Energy used and/or delivered | Similar | - |
| Compatibility with environment and other devices | Similar | - |
| Where used | Identical | - |
| Standards met | Unknown | - |
| Electrical safety | N/A | - |
| Thermal safety | Unknown | - |

The information above demonstrates that the TORQTECH device is substantially equivalent to the predicate device K#080677 in technological characteristics and is substantially equivalent to K#061701 in regard to materials.

The table below demonstrates that the LS spray included with the TORQTECH is substantially equivalent to the sprays authorized in K#070074 and K#012308.

| Name | LS spray | AR spray<br>K#070074 | KAVO<br>QUATTROcare<br>spray K#012308 | Comparison<br>result |
|-----------------|---------------------------------|----------------------|---------------------------------------|----------------------|
| Intended<br>use | Lubrication | Lubrication | Lubrication | Same |
| Materials 1 | Fatty acid ester<br>Mineral oil | Mineral oil | Fatty acid ester oil<br>Mineral oil | Similar |
| Materials 2 | Propane<br>Butane<br>Isobutane | Propane<br>Butane | Propane<br>Butane<br>Isobutane | Similar |

3

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#### 7. INDICATIONS FOR USE

TOROTECH transmits rotation of the motor to dental burrs and reamers which cut or grind teeth or dentures with the same or transformed rotation

#### 8. SUMMARY OF NON-CLINICAL TESTING

The TOROTECH was developed and tested in accordance with the following standards:

ISO 7785-2:1995 (dental handpieces - Part 2: straight and geared angle handpieces)

ISO 3964 (dental handpieces - coupling dimensions)

ISO 14971:2007 (medical devices - application of risk management to medical devices)

ISO 10993-1:2203 (biological evaluation of medical devices -- Part 1: evaluation and testing)

ISO 10993-5:2009 (biological evaluation: test for in vitro cytotoxicity)

ISO 10993-12:2007 (biological evaluation: sample preparation and reference materials)

ISO 17664:2004 (information to be provided by the manufacturer for the processing of resterilizable medical devices)

EN 980:2008 (graphical symbols for use in the labeling of medical devices)

EN 1041:2008 (information supplied by the manufacturer with medical devices)

The spray used with the TORQTECH device is considered a mucosal contacting substance of less than 24 hour duration under Annex A of ISO 10993-1: 2009. Results of sensitization and irritation testing under ISO 10993-1 showed the spray to not cause sensitization and that it is not an irritant. The cytotoxicity test results under ISO 10993-1, combined with risk analysis under ISO 14971:2007, demonstrate that the spray is suitable for the clinical application. Finally, with respect to the propellants in the spray, the same gases have been cleared for use in the Kavo predicate device K#012308.

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K103697

### 9. SUMMARY OF CLINICAL TESTING

No clinical tests were performed for the TORQTECH device.

### 10. CONCLUSION

The information above demonstrates that the TORQTECH device is substantially equivalent to the predicate devices.

40784440.doc

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Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name arranged in a circular fashion around a stylized symbol. The symbol is a graphic representation of an eagle or bird-like figure, with three distinct lines forming its body and wings.

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

J. Morita USA, Incorporated C/O Mr. Keith A. Barritt Attorney Fish & Richardson P.C. 1425 K Street N.W., Suite 1100 Washington, District of Columbia 20005

JAN. 2 0 2012

Re: K103697

Trade/Device Name: TORQTECH Regulation Number: 21 CFR 872:4200 Regulation Name: Dental Handpiece and Accessories Regulatory Class: I Product Code: EGS Dated: January 12, 2012 Received: January 13, 2012

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. 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. 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); 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 yours,

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

510(K) Number: Unknown TORQTECH Device Name: Indications for Use:

TORQTECH transmits rotation of the motor to dental burrs and reamers which cut or grind teeth or dentures with the same or transformed rotation.

AND/OR Prescription Use \ / (Part21CFR801 Subpart D)

Over-The-Counter Use (Part21CFR807 Subpart C)

(PLEASE) DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED Concurrence of CDRH, Office of Device Evaluation (ODE)

> (Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices

Susan Purrer

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number:

. (01