(185 days)
Not Found
No
The summary describes a mechanical dental drill/motor and makes no mention of AI or ML.
No
The device is described as a motor to drive attachments for drilling and polishing teeth, which are procedural functions rather than therapeutic.
No
The device description states it is "designed for dental treatment such as grinding, drilling and polishing teeth," indicating it is a therapeutic or procedural device rather than one used for diagnosing conditions or diseases.
No
The device description clearly states it is an "instrument" designed for dental treatment and is used as a "motor to drive attachments by air supplied from the treatment unit's air supply system." This indicates a physical, hardware-based device, not software.
Based on the provided information, the AIR TORX device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The description clearly states that the device is used as a motor to drive attachments for drilling and polishing teeth. This is a direct intervention on the patient's body (in vivo), not a test performed on samples taken from the body (in vitro).
- Device Description: The description reinforces its use for dental treatment like grinding, drilling, and polishing teeth, which are all in vivo procedures.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting substances, or providing diagnostic information based on laboratory tests.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, monitoring, or treatment of a disease or condition. The AIR TORX device's function is purely mechanical and used directly on the patient's teeth.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
EFB
Device Description
This instrument is designed for dental treatment such as grinding, drilling and polishing teeth.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
MICRO AIR MOTOR A-25LT, K944713
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
510(k) SUMMARY
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
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, DC 20005 Phone: (202) 783-5070 Facsimile: (202) 783-2331
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
1
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.
2
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.
3
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 (240) 276-0115. 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 (800) 638-2041 or (240) 276-3150 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
4
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
Page 1 of
510(k) Number: K091065