E-STATIS 40 SYSTEM

K090937 · Scican , Ltd. · EBW · Jul 24, 2009 · Dental

Device Facts

• Record ID: K090937
• Device Name: E-STATIS 40 SYSTEM
• Applicant: Scican , Ltd.
• Product Code: EBW · Dental
• Decision Date: Jul 24, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4200
• Device Class: Class 1

Intended 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.

Device Story

E-STATIS 40 is an electric motor system for dental handpieces; converts pneumatic output from dental treatment centers to power brushless micro motors. System includes power supply, control unit, hose, and motor. Operated by dental professionals via touch-screen panel; allows customization of torque and rotation speed (100-40,000 rpm). Features five endodontic modes (torque control, auto-stop, auto-forward, auto-reverse-forward) and three operative modes. Provides dentists with precise control over handpiece parameters during procedures; enhances clinical efficiency and procedural accuracy.

Clinical Evidence

Bench testing only. Performance testing evaluated rotational speed and torque measurements. Safety and efficiency validated through electrical safety, electromagnetic compatibility, and software verification/validation testing.

Technological Characteristics

Brushless micro motor; 100-40,000 rpm rotation speed; clockwise/counter-clockwise operation. Modular components; touch-screen control interface. Software-controlled torque and speed parameters. Electrical power supply. Tested for electrical safety and electromagnetic compatibility.

Indications for Use

Indicated for dental professionals performing restoration, prophylaxis, and endodontic procedures using electrically driven dental handpieces.

Regulatory Classification

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.

Predicate Devices

• OPTIMA MX (K042759)
• NuTorque (K083252)

Submission Summary (Full Text)

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K090937

# 510(K) Summary

E-STATIS 40 SYSTEM

JUL 2 4 2009

| Submitted by: | SciCan<br>1440 Don Mills Road<br>Toronto, Ontario Canada<br>M3B 3P9 | |
|----------------------|---------------------------------------------------------------------|----------------------------|
| Contact Person: | Brenda Murphy - Director of Regulatory Affairs<br>[phone] | |
| 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<br>510(k) K042759 | NuTorque<br>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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K090937

#### 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 [phone] or [phone] 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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K090937

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