(396 days)
K#080677, K#061701
K#070074, K#012308
No
The description focuses on mechanical transmission of rotational force and does not mention any computational or learning capabilities.
No
The device is described as a dental handpiece used for polishing, grinding, and drilling teeth/dentures, which are mechanical actions, not therapeutic.
No
The device is described as a dental handpiece used for polishing, grinding, and drilling teeth/dentures, which are therapeutic actions, not diagnostic. Its function is to transmit rotational force for these procedures.
No
The device description clearly states it is a dental handpiece that transmits rotational force from a motor to dental burrs or reamers, indicating it is a physical hardware device.
Based on the provided information, the TORQTECH device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to transmit rotation for cutting or grinding teeth or dentures. This is a direct mechanical action on the patient's body (or a prosthetic).
- Device Description: The description details a dental handpiece that attaches to a motor to perform physical procedures like polishing, grinding, and drilling.
- Lack of IVD Characteristics: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The TORQTECH does not interact with or analyze such specimens.
The TORQTECH is a dental instrument used for physical manipulation of teeth and dentures, not for in vitro diagnostic testing.
N/A
Intended Use / 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.
Product codes
EGS
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
teeth or dentures
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
No clinical tests were performed for the TORQTECH device.
The TORQTECH 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K#080677, K#061701
Reference Device(s)
K#070074, K#012308
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.4200 Dental handpiece and accessories.
(a)
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.(b)
Classification. Class I.
0
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: 949-581-9600 Facsimile: 949-581-9688
Registration No. 3002807636 Manufacturer J. MORITA MFG. CORP. 680 Higashihama Minami-cho Fushimi-ku, Kyoto Japan 612-8533 +81-75-611-2141 +81-75-605-2354
3. CONTACT PERSON
Keith A. Barritt Fish & Richardson P.C. 1425 K Street, N.W. . Suite 1100 Washington, D.C. 20005 Telephone: (202) 783-5070 Facsimile: (202) 783-2331
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:
1
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:
2
| 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
K#070074 | KAVO
QUATTROcare
spray K#012308 | Comparison
result |
|-----------------|---------------------------------|----------------------|---------------------------------------|----------------------|
| Intended
use | Lubrication | Lubrication | Lubrication | Same |
| Materials 1 | Fatty acid ester
Mineral oil | Mineral oil | Fatty acid ester oil
Mineral oil | Similar |
| Materials 2 | Propane
Butane
Isobutane | Propane
Butane | Propane
Butane
Isobutane | Similar |
3
3
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.
4
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
5
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.
6
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 (800) 638-2041 or (301) 796-7100 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
7
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