(71 days)
Not Found
No
The description details a microprocessor-controlled device with specific, user-settable parameters and pre-programmed control modes (like ATC and Auto control). There is no mention of learning, adaptation, or complex pattern recognition beyond these defined rules, which are characteristic of traditional control systems, not AI/ML.
Yes
The device is intended to measure the length of the root canal and enlarge it, while also monitoring the position of the file tip. These functions are directly involved in the treatment and preparation of the root canal, making it a therapeutic device.
Yes
The device is a diagnostic device because it "can measure the length of the root canal" and "monitors the position of the file tip inside the canal," which are diagnostic functions. The "Apex Locator" also measures the distance between the file tip and Apex.
No
The device description explicitly details hardware components such as a plastic enclosure, electrical connection ports, a detachable power supply cord, a foot-control, a micro-motor, and a reference electrode (lip connector). It also describes the physical function of the micro-motor and its interaction with the file.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- TCM Endo V Function: The TCM Endo V is a dental device used directly on the patient's tooth (specifically, the root canal) to measure length and enlarge the canal. It does not analyze specimens taken from the body.
- Intended Use: The intended use clearly states it's for "measuring the length of the root canal and enlarging the canal while monitoring the position of the file tip inside the canal." This is a procedural device, not a diagnostic one based on in vitro analysis.
- Device Description: The description details the mechanical and electrical functions of the device for performing a dental procedure. It doesn't mention any components or processes related to analyzing biological samples.
Therefore, based on the provided information, the TCM Endo V is a dental procedural device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The TCM Endo V is a dental root canal measurement and treatment device that can measure the length of the root canal and enlarge the root canal while monitoring the position of the file tip inside the canal.
Product codes (comma separated list FDA assigned to the subject device)
EKX
Device Description
The TCM Endo V is a transportable, cord connected, microprocessor-controlled endodontic device with Apex Locator. It is provided with a plastic enclosure which has four electrical connection ports for the detachable power supply cord, the foot-control, the micro-motor and the reference electrode (lip connector).
The Apex Locator measures the distance between file tip and Apex. If a minimum distance is preselected, the selected auto-control mode is activated thus ensuring that the minimum distance is reached.
The speed is held constantly under all circumstances until the maximum adjusted torque limit is reached. The Automatic Torque Control (ATC) protection mode ensures that no file breakage occurs. Once the preselected torque limit has been reached, the motor will immediately reverse for one revolution, then returns to forward direction. This ensures a fast and effective root canal preparation.
The following parameters can be set by the user;
- mains voltage (100V/115V/230V) -
- rotational speed (150-2000 rpm)
- "Apex adjust" (-1 to 0) -
- automatic torque limitation "ATC" (5-40Nmm) -
- "Auto control" mode ("Auto Slow / Down", "Auto Reverse"; "Auto Stop") -
- micro-motor ON/OFF "Motor"
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Root canal
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 TCM Endo V has been designed and tested to applicable safety standards. The TCM Endo V does not raise any new issues of safety, effectiveness, or performance of the product.
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
NOUVAG AG TCM Endo V
510(k) Notification October 08, 2004
DEC 22 2004
SECTION 10
510(k) Summary
Submitter:
NOUVAG AG St. Gallerstrasse 23-25 CH-9403 Goldach Switzerland
Contact Person: Benno Frei Technical Director, New Product Development Phone 0041 71 846 66 00 0041 71 845 35 36 Fax
Date Summary Prepared: October 08, 2004
Device Name:
Proprietary Name TCM Endo V Common Name Endodontic Device with Apex locator Classification Name Handpiece, Direct Drive, Ac-powered (per 21 CFR section 872.4200)
Identification of the predicate device or legally marketed device or devices to which substantial equivalence is being claimed:
J. Morita USA, Inc. DENTAPORT ZX K031204, Cleared on 08/21/2003
J. Morita USA, Inc. DENTA PORT K022147, Cleared on 12/20/2002
1
Device Description:
The TCM Endo V is a transportable, cord connected, microprocessor-controlled endodontic device with Apex Locator. It is provided with a plastic enclosure which has four electrical connection ports for the detachable power supply cord, the foot-control, the micro-motor and the reference electrode (lip connector).
The Apex Locator measures the distance between file tip and Apex. If a minimum distance is preselected, the selected auto-control mode is activated thus ensuring that the minimum distance is reached.
The speed is held constantly under all circumstances until the maximum adjusted torque limit is reached. The Automatic Torque Control (ATC) protection mode ensures that no file breakage occurs. Once the preselected torque limit has been reached, the motor will immediately reverse for one revolution, then returns to forward direction. This ensures a fast and effective root canal preparation.
The following parameters can be set by the user;
- mains voltage (100V/115V/230V) -
- rotational speed (150-2000 rpm)
- "Apex adjust" (-1 to 0) -
- automatic torque limitation "ATC" (5-40Nmm) -
- "Auto control" mode ("Auto Slow / Down", "Auto Reverse"; "Auto Stop") -
- micro-motor ON/OFF "Motor"
Sterility:
Contra Angle, Motor and motor cable, and lip connector: Sterility by user up to 134°C.
Intended use of the Devices:
The TCM Endo V is a dental root canal measurement and treatment device that can measure the length of the root canal and enlarge the root canal while monitoring the position of the file tip inside the canal.
Statement of how the technological characteristics of the device compare to those of the predicate or legally marketed device:
The TCM Endo V is substantially equivalent to other legally marketed devices in the United States. The TCM Endo V functions in a manner similar and are intended for the same use as the Devices designed by J. Morita USA, Inc.
Brief summary of nonclinical tests and results:
The TCM Endo V has been designed and tested to applicable safety standards. The TCM Endo V does not raise any new issues of safety, effectiveness, or performance of the product.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure with three curved lines representing its wings or body.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 22 2004
NOUVAG AG C/O Mr. Erich Forster Regulatory Consultant INTRATest Systems GmbH Reusswehrstrasse 1 CH-5412 Gebenstorf / Switzerland
Re: K042822
Trade/Device Name: TCM Endo V Regulation Number: 872.4200 Regulation Name: Dental Handpiece and Access Series Regulatory Class: I Product Code: EKX Dated: October 8, 2004 Received: October 12, 2004
Dear Mr. Forster:
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 either class II (Special Controls) or class III (PMA), it may be subject to such 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
Page 2 - Mr. Forster
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) 276-0115. 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Anthony D. 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
4
NOUVAG AG TCM Endo V
510(k) Notification October 08, 2004
510(k) Number (if known): K042822
Device Name: TCM Endo V
Indications for Use:
The TCM Endo V is a dental root canal measurement and treatment device that can measure the length of the root canal and enlarge the canal while monitoring the position of the file tip inside the canal.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurence of CDRH, Office of Device Evaulation (ODE)
(Optional Format 3-10-98)
Prescription use
(per 21 CFR 801.109)
... ...
OR
Over-The-Counter Use
Ken Mcaley for HSE
(Division Sign-Off) (Civision Sign-Only)
Division of Anesthesiology, General Hospital, Division Control, Dental Devices
510(k) Number: K042822