(234 days)
Not Found
No
The description focuses on mechanical and electrical functions (motor, chuck, battery, connection to apex locator) and standard performance testing (electrical safety, biocompatibility, sterilization, software validation). There is no mention of AI, ML, image processing, or data-driven decision-making.
Yes
The device is used to enlarge and prepare root canals, remove gutta-percha points, and for professional tooth cleaning, which are therapeutic interventions.
No
The device is primarily used for mechanical preparation of root canals (enlarging and shaping). While it can indicate the position of a file tip when connected to an apex locator (which itself is a diagnostic tool for measuring length), the Tri Auto mini itself is not performing a diagnostic function; it is a tool for treatment.
No
The device description explicitly states it is a "battery-driven handpiece with a motor, equipped with the chuck for holding rotary instrument". This indicates it is a physical hardware device, not software only.
Based on the provided information, the Tri Auto mini motorized handpiece is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body. The Tri Auto mini is a tool used directly on the patient's teeth and root canals.
- The intended uses described (enlarging and preparing root canals, removing gutta-percha, professional tooth cleaning, measuring root canal length) are all procedures performed directly on the patient. They do not involve analyzing a sample taken from the patient.
- The device description confirms it's a handpiece with a motor and chuck for instruments used within the root canal.
Therefore, the Tri Auto mini is a dental device used for treatment and measurement within the patient's mouth, not for in vitro diagnostic testing of biological samples.
N/A
Intended Use / Indications for Use
The Tri Auto mini motorized handpiece can be used to enlarge and prepare root canals, remove gutta-percha points, and for professional tooth cleaning. When connected to Apex locator, the Tri Auto mini can be used to measure the length of root canals.
Product codes (comma separated list FDA assigned to the subject device)
EKX
Device Description
The Tri Auto mini is an battery-driven handpiece with a motor, equipped with the chuck for holding rotary instrument such as a dental file and a reamer. Tri Auto mini can be used for enlargement and preparation of root canals. When connected to Apex Locator (which is not included in this application), the Tri Auto mini indicates the position of the file tip inside the root canal.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Similar
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)
The Tri Auto mini was tested in accordance with IEC 60601-1, IEC 60601-1-4, UL 60601-1, CAN/CSA C 22.2 No.601.1-M90, and IEC 60601-1-2. Also, Biocompatibility, sterilization, and software validation were conducted.
Test results shows that Tri Auto mini is substantially equivalent to predicate devices.
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.
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
Kllalds
510(k) SUMMARY
---. ...
MAY - 4 2012
J. MORITA USA Inc.'s Tri Auto mini
1. NAME OF DEVICE
Common/Usual Name: Device trade or proprietary name: Tri Auto mini Product Model :
Endodontic Treatment Motorized Handpiece TR-CM
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: August 5, 2011
5. DEVICE CLASSIFICATION/CLASSIFICATION PANEL
Device: Endodontic Treatment Motorized Handpiece Review Panel: 872 Dental Product Code: EKX Device Class: Class I
1
6. DEVICE DESCRIPTION/SUBSTANTIAL EQUIVALENCE
DEVICE DESCRIPTION
. 1;
The Tri Auto mini is an battery-driven handpiece with a motor, equipped with the chuck for holding rotary instrument such as a dental file and a reamer. Tri Auto mini can be used for enlargement and preparation of root canals. When connected to Apex Locator (which is not included in this application), the Tri Auto mini indicates the position of the file tip inside the root canal.
SUBSTANTIAL EQUIVALENCE
The Tri Auto mini is substantially equivalent to Tri Auto ZX (K921979 / K953867) and ROOT ZX II (K071190).
1) Predicate device I : Tri Auto ZX (K921979 / K953867)
The Tri Auto mini is substantially equivalent to Tri Auto ZX from J.MORITA MFG.CORP. The Tri Auto mini has similar general intended uses, similar principles of operation, and similar technological characteristics to the predicate device Tri Auto ZX (K970339).
2) Predicate device II : ROOT ZX II (K071190)
The Tri Auto mini is substantially equivalent to ROOT ZX II (K071190) from J.MORITA MFG.CORP. The Tri Auto mini has similar general intended uses, similar principles of operation, and similar technological characteristics to the predicate device, ROOT ZX II (K071190).
PERFORMANCE TESTING
The Tri Auto mini was tested in accordance with IEC 60601-1, IEC 60601-1-4, UL 60601-1, CAN/CSA C 22.2 No.601.1-M90, and IEC 60601-1-2. Also, Biocompatibility, sterilization, and software validation were conducted.
Test results shows that Tri Auto mini is substantially equivalent to predicate devices.
2
| Predicate devices | ||
|---|---|---|
| TECHNOLOGICAL | ||
| CHARACTERISTICS of | ||
| Tri Auto mini | Tri Auto ZX | |
| (K970339) | ROOT ZX II | |
| (K071190) | ||
| Indication for use | ||
| Canal Enlargement Function | Identical | Identical |
| Target population | Identical | Identical |
| Design | Similar | Different |
| Materials | Similar | Similar |
| Performance | ||
| Canal Enlargement Function | Identical | Identical |
| Sterility | Similar | Similar |
| Biocompatibility | Similar | Similar |
| Mechanical safety | Identical | Identical |
| Chemical safety | Identical | Identical |
| Anatomical sites | Similar | Similar |
| Human factors | Similar | Similar |
| Energy used and/or delivered | Different | Different |
| Compatibility with environment | ||
| and other devices | Similar | Similar |
| Where used | Identical | Identical |
| Standards met | Similar | Identical |
| Electrical safety | Similar | Identical |
| Thermal safety | Identical | Identical |
Table- 1 Comparison summary table
7. INDICATIONS FOR USE
The Tri Auto mini motorized handpiece can be used to enlarge and prepare root canals, remove gutta-percha points, and for professional tooth cleaning. When connected to Apex locator, the Tri Auto mini can be used to measure the length of root canals.
8. Conclusion
Based on the information provided in this premarket notification, the Tri Auto mini is substantially equivalent to the Tri Auto ZX (K970339) and the ROOT ZX II (K071190).
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized eagle-like symbol with three curved lines representing the body and wings.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room-WO66-G609 Silver Spring, MD 20993-0002
J. Morita USA, Inc. C/O Mr. Keith A. Barritt Attorney Fish & Richardson P.C. 1425 K Street NW Suite 1100 Washington. District of Columbia 20005
MAY - 4 2012
Re: K112665
Trade/Device Name: Tri Auto Mini (Endodontic Treatment Motorized Handpiece) Regulation Number: 21 CFR 872.4200 Regulation Name: Dental handpiece and accessories. Regulatory Class: I Product Code: EKX Dated: April 30, 2012 Received: May 1, 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.
4
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,
Nh 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
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Indications for Use
510(k) Number (if known): unknown
Device Name: Tri Auto mini (Endodontic Treatment Motorized Handpiece)
Indications For Use:
- The Tri Auto mini motorized handpiece can be used to enlarge and prepare root canals,
- . remove gutta-percha points, and for professional tooth cleaning.
- When connected to Apex locator, the Tri Auto mini can be used to measure the length of root canals.
Susan Runge
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K112665
× 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)