(112 days)
Not Found
No
The description focuses on motor control, customizable settings, and a touch screen interface, with no mention of AI or ML capabilities.
No.
The device is described as a control system for electrically driven dental handpieces, intended for use in dental restoration, prophylaxis, and endodontic procedures. While these procedures are therapeutic, the device itself is a power and control unit for tools, not directly administering therapy to a patient.
No
This device is described as an electric motor system intended for use in dental restoration, prophylaxis, and endodontic procedures, providing control for motorized handpieces. Its primary function is to operate dental tools, not to diagnose conditions.
No
The device description explicitly states that the system is comprised of a power supply, control unit, hose, and a brushless micro motor, which are all hardware components.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "dental restoration, prophylaxis and endodontic procedures." These are clinical procedures performed directly on a patient's teeth and surrounding tissues.
- Device Description: The description details a system for controlling motorized dental handpieces, which are tools used in these clinical procedures.
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not perform any such analysis of biological specimens.
The E-STATIS type 40 dental system is a piece of equipment used during dental procedures, not for diagnosing conditions based on in vitro analysis.
N/A
Intended Use / Indications for Use
The E-STATIS type 40 dental system is intended for use by dental professionals in the performance of dental restoration, prophylaxis and endodontic procedures.
The E-STATIS 40 System is intended for use in dentistry for restoration, prophylaxis and endodontic procedures. The system provides control for motorized handpieces by converting pneumatic output from the dental treatment center to permit the operation of electrically driven dental handpieces.
Product codes
EBW
Device Description
The E-STATIS type 40 Electric Motor System is designed for use in various dental procedures including dental restoration, prophylaxis and endodontics. The system is comprised of a power supply, control unit, hose and a brushless micro motor.
The control unit is equipped with five customizable endo settings including torque control, with the option of auto-stop, auto-forward and auto-reverse-forward. In addition, there are also three standard customizable operative modes. All E-STATIS components are modular and can be placed wherever the operator chooses.
The inputs to the control unit are supplied by a control panel with touch screen operation. The touch-sensitive screen has clear, user friendly symbols and provides individual selection and usage of the parameters to the individual needs of the dentist. The touch pad is removable and can be mounted either internally or externally on the dental unit.
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
dental professionals, dentistry
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)
Performance testing was conducted to evaluate the rotational speed and torque measurements of the devices. Testing was also conducted to validate the safety and efficiency of the device, including electrical safety, electromagnetic compatibility and validation verification testing of the software.
Testing was conducted in accordance with recognized standards.
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
1072
510(K) Summary
E-STATIS 40 SYSTEM
JUL 2 4 2009
| Submitted by: | SciCan
1440 Don Mills Road
Toronto, Ontario Canada
M3B 3P9 | |
|----------------------|---------------------------------------------------------------------|----------------------------|
| Contact Person: | Brenda Murphy - Director of Regulatory Affairs
(416) 446-2797 | |
| Date of Preparation: | March 23, 2009 | |
| Name of Device: | E-STATIS 40 Electric Motor System | |
| Common name: | Controller, Foot, Handpiece and Cord | |
| Classification name: | Dental Handpiece and Accessories | |
| Predicate Device: | OPTIMA MX
510(k) K042759 | NuTorque
510(k) K083252 |
Description of Device:
The E-STATIS type 40 Electric Motor System is designed for use in various dental procedures including dental restoration, prophylaxis and endodontics. The system is comprised of a power supply, control unit, hose and a brushless micro motor.
The control unit is equipped with five customizable endo settings including torque control, with the option of auto-stop, auto-forward and auto-reverse-forward. In addition, there are also three standard customizable operative modes. All E-STATIS components are modular and can be placed wherever the operator chooses.
The inputs to the control unit are supplied by a control panel with touch screen operation. The touch-sensitive screen has clear, user friendly symbols and provides individual selection and usage of the parameters to the individual needs of the dentist. The touch pad is removable and can be mounted either internally or externally on the dental unit.
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Intended use:
The E-STATIS type 40 dental system is intended for use by dental professionals in the performance of dental restoration, prophylaxis and endodontic procedures.
Technological Characteristics:
The micro motor has a rotation speed of 100 - 40000 rpm and can be rotated in a clockwise or counter clockwise direction. Performance testing was conducted to evaluate the rotational speed and torque measurements of the devices. Testing was also conducted to validate the safety and efficiency of the device, including electrical safety, electromagnetic compatibility and validation verification testing of the software.
Testing was conducted in accordance with recognized standards.
Substantial Equivalence:
Substantial equivalence was determined on the basis that the proposed device and the predicate devices were substantially equivalent in that they have the same intended use; the same operating principles; and a similar technology and design.
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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 three stripes extending from its wing, symbolizing service and protection. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Brenda Murphy Director of Regulatory Affairs SciCan, Limited 1440 Don Mills Road Toronto, Ontario Canada, M3B 3P9
JUL 2 4 2009
Re: K090937
Trade/Device Name: E-Statis 40 System Regulation Number: 21 CFR 872.4200 Regulation Name: Dental Handpiece and Accessories Regulatory Class: I Product Code: EBW Dated: July 22, 2009 Received: July 23, 2009
Dear Ms. Murphy:
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 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.
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Page 2- Ms. Murphy
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/cdrh/mdr/ 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Susan Runares
Susan Runner, D.D.S., M.A. Acting Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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1
INDICATIONS FOR USE
510(k) Number (if known):
Device Name:
E-STATIS 40 System
Indications for Use:
The E-STATIS 40 System is intended for use in dentistry for restoration, prophylaxis and endodontic procedures. The system provides control for motorized handpieces by converting pneumatic output from the dental treatment center to permit the operation of electrically driven dental handpieces.
Typical users of this system are trained dental professionals.
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)
Office of Device Evaluation (ODE)
(Division Sign-Off) Division of Anesthesiology, General Hospital infection Control, Dental Devices
510(k) Number: K090931
SCICAN E-STATIS 40 SYSTEM