(65 days)
Analytic Endodontics, Quantec-E Endo System
Not Found
No
The description focuses on the mechanical and electrical components of an endodontic unit and does not mention any AI or ML capabilities.
No
The device is described as an endodontic unit intended to drive dental handpieces during root canal 'preparation,' which implies a mechanical function rather than a therapeutic one like treating a disease or disorder directly. It's an instrument used for a procedure.
No
The text describes the device as an endodontic unit intended to drive dental handpieces during root canal preparation, which is a treatment procedure, not a diagnostic one.
No
The device description explicitly states it consists of a controller console, foot pedal, and motor, which are hardware components.
Based on the provided information, the TCM Endo III is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is "to drive dental handpieces during root canal preparation." This is a procedure performed directly on a patient's tooth, not on a sample taken from the body.
- Device Description: The description details a motor and control unit used for mechanical action (driving handpieces), not for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing blood, tissue, or other biological specimens, which is the core function of an IVD.
IVD devices are used to examine specimens derived from the human body to provide information for diagnosis, monitoring, or screening. The TCM Endo III is a tool used for a dental procedure.
N/A
Intended Use / Indications for Use
The intended use of the TCM Endo III is to drive dental handpieces during root canal preparation.
The TCM Endo III is an AC-powdered endodontic unit consisting of a controller console, foot pedal and motor intended to drive dental handpieces during root canal preparation.
Product codes
EFA
Device Description
The TCM Endo III is an AC-powdered endodontic unit consisting of a controller console, foot pedal and motor intended to drive dental handpieces during root canal preparation. The motor has a maximum 1:1 drive output of 16,000 Rpm's. The unit is supplied with either a 115V or 230V power cord. The entire motor assembly of the TCM Endo III is autoclavable.
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Analytic Endodontics, Quantec-E Endo System
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
NOV 2 82001
SYBRON DENTAL SP
Section III - 510(k) Summary of Safety and Effectiveness
Submitter:
Nouvag, A.G. St. Gallerstrasse, 23-25 CH-9403 Goldach Switzerland
Contact:
Colleen Boswell Sybron Dental Specialties, Inc. (714) 516-7484 - Phone (714) 516-7488 - Facsimile
Date Summary Prepared:
September 2001
Device Name:
-
Trade Name TCM Endo III .
K વ 3185 -
Common Name AC-Powered Dental handpiece .
-
Classification Name Dental Handpiece and Accessories, per 21 CFR § 872.4200 .
Devices for Which Substantial Equivalence is Claimed:
- Analytic Endodontics, Quantec-E Endo System .
Device Description:
The TCM Endo III is an AC-powdered endodontic unit consisting of a controller console, foot pedal and motor intended to drive dental handpieces during root canal preparation. The motor has a maximum 1:1 drive output of 16,000 Rpm's. The unit is supplied with either a 115V or 230V power cord. The entire motor assembly of the TCM Endo III is autoclavable.
Intended Use of the Device:
The intended use of the TCM Endo III is to drive dental handpieces during root canal preparation.
Substantial Equivalence:
TCM Endo III is substantially equivalent to other legally marketed devices in the United States. TCM Endo III functions in a manner similar to and is intended for the same use as the Quantec-E Endo System designed by Analytic Endodontics.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with three curved lines representing its body and wings. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 2 8 2001
Nouvag AG C/O Ms. Colleen Boswell Consultant Sybron Dental Specialties, Incorporated . 1717 West Collins Avenue Orange, California 92867
Re: K013185
Trade/Device Name: TCM Endo III Regulation Number: 872.4200 Regulation Name: AC-Powered Dental Handpiece Regulatory Class: I Product Code: EFA Dated: September 21, 2001 Received: September 24, 2001
Dear Ms. Boswell:
We have reviewed your Section 510(k) premarket notification of intent to market the device we have roviewed your betermined the device is substantially equivalent (for the releveloco above and nove atternslosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device mendments, or to devices that have been reclassified in accordance with the provisions of Amendinents, or to act 1000 Cosmetic Act (Act) that do not require approval of a premarket the rodelar F ood, Drag, and Country, therefore, market the device, subject to the general approvin application (1 the Act. The general controls provisions of the Act include controls providents of an 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 If your device is classified (see as 10)ional controls. Existing major regulations affecting (1 Writ), it may of back of Federal Regulations, Title 21, Parts 800 to 898. In your device ear or rounder further announcements concerning your device in the Federal Register.
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
2
Page 2 - Ms. Boswell
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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,
Timothy A. Ulatowski
Tim Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
3
Section I
Indications for Use Statement
er/ 3 Number (if known) Device Name: TCM Endo III Indications For Use: The TCM Endo III is an AC-powdered endodontic unit consisting of a controller console, foot
gedal and motor intended to drive dental handpieces during root canal preparation. (Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘ 的 (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NBEDISD Concurrence of CDRH, Office of Device Evaluation (ODE) (Per 21 CFR 801.109) (Optional Format 1-2-96)