(101 days)
Not Found
No
The description details a microprocessor-controlled motor system with pre-set torque control modes (AL and AR). There is no mention of learning, adaptation, or complex pattern recognition that would indicate AI/ML. The control logic appears to be rule-based and deterministic.
Yes
The device is used for dental root treatment, which involves enlarging the root canal. This is a medical procedure intended to treat a diseased or damaged tooth, thus qualifying it as a therapeutic device.
No
The device is used for enlarging the root canal with a rotating file, which is a treatment function, not a diagnostic one.
No
The device description explicitly states it is "transportable, cord connected equipment, provided with a plastic enclosure which has two connection ports for the footswitch and the electronic motor." This indicates it is a physical hardware device, not software only.
Based on the provided information, the TCM Endo 20 is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is "a dental root treatment device for enlarge the root canal with a rotating, high elastic file." This describes a device used directly on a patient's tooth (in vivo) for a therapeutic procedure.
- Device Description: The description details a motor system, handpiece adapter, and controls for speed and torque. These are components of a device used for mechanical manipulation within the root canal.
- Anatomical Site: The anatomical site is the "root canal," which is part of the human body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, tissue, or urine) outside of the body to provide information for diagnosis, monitoring, or screening.
IVD devices are specifically designed to perform tests on samples taken from the human body. The TCM Endo 20 is a tool used for a dental procedure performed directly on the patient.
N/A
Intended Use / Indications for Use
The TCM Endo 20 is a dental root treatment device for enlarge the root canal with a rotating, high elastic file.
Product codes
EKX
Device Description
The TCM Endo 20 is a transportable, cord connected equipment, provided with a plastic enclosure which has two connection ports for the footswitch and the electronic motor. It is a microprocessor controlled electronic motor system which controls the rotational speed and the torque of the motor. The rotational speed is constant until the torque reaches the adjusted level. In order to protect the rimmer, you can choose between two torque controlling modes -the Automatic Limiter (AL) and the Automatic Reverse (AR) mode. The electronic motor has a standard E-type handpiece adapter that accepts any E-type contra angle and handpiece (E-fitting). The following parameters can be set by the user: - "Speed" increase or decrease rotational speed - "Torque" select torque maximum - -"Motor" -- Switch on/off electronic motor - "Ratio" Select ratio of the contra angle - -"Symbol reverse" - Select rotating direction: R (Right) clockwise: L (Left, reverse) counterclockwise - -"Prog" - Select Program 1 to 9 - -"AL/AR" - Choose between AL- and AR- mode
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 20 has been designed and tested to applicable safety standards. The TCM Endo 20 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)
Reference Device(s)
Not Found
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
NOUVAG AG TCM Endo 20
510(k) Notification April 16, 2008 :
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SECTION 5
AUG - 7 2008
510(k) Summary
Submitter: NOUVAG AG St. Gallerstrasse 23-25 CH-9403 Goldach Switzerland
Contact Person: Markus Gemperle Quality Manager / RA Phone +41 71 846 66 00 +41 71 845 35 36 Fax
Date Summary Prepared: April 16, 2008
Device Name:
Proprietary Name TCM Endo 20
Common Name Endodontic Device
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:
NOUVAG AG TCM Endo V K042822, Cleared on 12/22/2004
1
Device Description:
The TCM Endo 20 is a transportable, cord connected equipment, provided with a plastic enclosure which has two connection ports for the footswitch and the electronic motor. It is a microprocessor controlled electronic motor system which controls the rotational speed and the torque of the motor. The rotational speed is constant until the torque reaches the adjusted level.
In order to protect the rimmer, you can choose between two torque controlling modes -the Automatic Limiter (AL) and the Automatic Reverse (AR) mode.
The electronic motor has a standard E-type handpiece adapter that accepts any E-type contra angle and handpiece (E-fitting).
The following parameters can be set by the user:
- "Speed" increase or decrease rotational speed
- "Torque" select torque maximum
- -"Motor" -- Switch on/off electronic motor
- "Ratio" Select ratio of the contra angle -
- -"Symbol reverse" - Select rotating direction: R (Right) clockwise: L (Left, reverse) counterclockwise
- -"Prog" - Select Program 1 to 9
- -"AL/AR" - Choose between AL- and AR- mode
Sterility:
Motor and motor cable: Sterility by user up to 134°C.
Intended use of the Devices:
The TCM Endo 20 is a dental root treatment device for enlarge the root canal with a rotating, high elastic file.
Statement of how the technological characteristics of the device compare to those of the predicate or legally marketed device:
The TCM Endo 20 is substantially equivalent to other legally marketed devices in the United States. The TCM Endo 20 functions in a manner similar and is intended for the same use as the TCM Endo V (Predicate device)
Brief summary of nonclinical tests and results:
The TCM Endo 20 has been designed and tested to applicable safety standards. The TCM Endo 20 does not raise any new issues of safety, effectiveness, or performance of the product.
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle, indicating the department's name and national affiliation.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG - 7 2008
NOUVAG AG C/O Ms. Erich Forster Quality Manager / Regulatory Affairs INTRATest GmbH Reusswehrstrasse 1 Gebenstorf CH-5412 SWITZERLAND
Re: K081191
Trade/Device Names: TCM Endo 20 Regulation Number: 21 CFR 872.4200 Regulation Name: Dental Handpiece and Accessories Regulatory Class: I Product Code: EKX Dated: July 8, 2008 Reccived: July 14, 2008
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: registertion 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation cntitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 vours.
Sincerely yours,
TH Normuly ferdi r-2
pxu
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
K081191
510(k) Number (if known):
Device Name: TCM Endo 20
Indications for Use:
The TCM Endo 20 is a dental root treatment device for enlarge the root canal with a rotating, high elastic file.
(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 X
(per 21 CFR 801.109)
OR
Over-The-Counter Use_
Susan Ryner
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
1971-191 510(k) Number: