E3 TORQUE CONTROL MOTOR

K103653 · Dentsply International, Inc. · EBW · May 26, 2011 · Dental

Device Facts

• Record ID: K103653
• Device Name: E3 TORQUE CONTROL MOTOR
• Applicant: Dentsply International, Inc.
• Product Code: EBW · Dental
• Decision Date: May 26, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4200
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

The e3 Torque Control Motor is a medical device designed for use by dentists for use with dental root canal instruments in continuous rotation with torque control or in reciprocating movement.

Device Story

The e3 Torque Control Motor is an electric motor-driven handpiece for endodontic procedures. It consists of a control unit with an LCD screen and a 6:1 contra-angle handpiece. The device operates in continuous rotation or reciprocating modes. Dentists can program 15 custom settings for speed and torque control. The motor connects to a power supply and includes a battery. The device prevents rotary files from exceeding required torque strength. It is used by dentists in a clinical setting. The device includes a USB port for manufacturer-facilitated software updates. The system provides controlled mechanical motion for endodontic instruments, assisting the clinician in root canal preparation.

Clinical Evidence

No clinical data. Substantial equivalence is supported by bench testing, including electrical safety, electromagnetic compatibility, and software validation per EN 62304. Biocompatibility of patient-contact components was confirmed per ISO 10993.

Technological Characteristics

Electric motor-driven handpiece with 6:1 contra-angle. Console housing: PC/ABS blend. Power: Battery with AC charger. Connectivity: USB port for software updates. Standards: ISO 10993 (biocompatibility), EN 60601-1 (electrical safety), EN 60601-1-2 (EMC), EN 60601-1-8 (alarm systems), EN 62304 (software). Features: Torque control, continuous and reciprocating motion modes, 15 programmable settings.

Indications for Use

Indicated for use by dentists for operating dental root canal instruments in either continuous rotation with torque control or reciprocating movement.

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

• X-Smart™ Easy (K092614)

Submission Summary (Full Text)

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K103653

## MAY 2 6 2011

## SECTION 5. 510(k) SUMMARY for e3 Torque Control Motor

#### Submitter Information: 1.

DENTSPLY International Susquehanna Commerce Center 221 West Philadelphia Street York, PA 17405

| Contact Person: | Helen Lewis |
|-------------------|--------------|
| Telephone Number: | 717-849-4229 |
| Fax Number: | 717-849-4343 |

Date Prepared: 10 December 2010

- Device Name: 2.
- Proprietary Name: .
- Common Name: .
- Classification Name: .
- CFR Number: 0
- Device Class: .
- EKX Product Code: .

#### Predicate Device: 3.

X-Smart™ Easy, K092614

#### Description of Device: 4.

The e3 Torque Control Motor is an electric motor-driven handpiece intended for The 05 Torque come of the endodontic industry. It works in both reciprocating mode and continuous rotation. This motor is provided with preroofbrounding mode and nickel titanium rotary file systems sold by DENTSPLY. programmed octings the dentist to program 15 settings of their choice for speed and torque control.

e3TM Torque Control Motor

Dental Handpiece and Accessories

dental motor

872.4200

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The device consists of a control unit with an LCD screen for selection of settings. I he device connected to the control unit so the dentist can selectively activate A 1001 pean 13 comnected to nower supply is also connected to the control unit to allo dealer valo the motor is connected to the control unit and a 6:1 contra charge the battery. This angle is cleared under K972436. Files attach to the contra angle.

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#### Indications for Use: રુ.

The e3 Torque Control Motor is a medical device designed for use by dentists for The CS Torque Conner More ruments in continuous rotation with torque control or in reciprocating movement.

- Description of Safety and Substantial Equivalence: ર. Technological Characteristics
The technological similarities of the two devices are as follows:

Both meet the requirements for Biocompatibility per ISO 10993, the . Electromagnetic Compatibility and Electrical Safety Requirements conforming to EN 60601-1 and EN 60601-1-2, and EN 60601-1-8.

- Both devices meet the requirements for Software Validation per EN 62304. .
- Both devices have the same type of power source- battery with AC charger. .

Both devices have a torque control feature which prevents the . rotary file from exceeding its required torque strength.

The e3 Torque Control Motor (subject device) and the X-Smart Easy motor (predicate device) have minor technological differences:

The X-Smart East Motor has a cordless handpiece. The e3 Torque Control . Motor has a cord attachment to the handpiece.

The X-Smart Easy motor is designed for continuous rotation motion only. . The e3 Torque Control Motor is designed for both continuous rotation as well as reciprocating motion.

The gear ratios for the contra angles are different for the two devices. .

- The e3 has a USB port for software update capabilities via the manufacturer. .
The X-Smart East motor has a push button on the handpiece for motor ♥ · The X-Smart Last motor has a pass. Canton can be operated with either the foot pedal or the console.

The console house for the X-Smart Easy is ABS- the e3 console housing is a PC/ABS blend.

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## Non-Clinical Performance Data.

#### Biocompatibility Testing

Diocompanently Forms
Cytotoxicity was performed for the Sirona Endo 6:1 contra angle in accordance with ISO 10993. All patient contact components demonstrated biocompatibility.

# Electromagnetic Compatibility and Electrical Safety

Electromagnette Companisms andorms to EN 60601-1: 2007 Medical Electrical Equipment, Part 1: General Requirements for Safety, EN 60601-1-8:2007 Equipment, I ar 11 Octoberns In Medical Electrical Equipment and Medical Gardailor For + main by Frid 60601-1-2:2007 Electromagnetic Compatibility -Requirements and Tests

#### Software validation

Both devices meet software validation requirements per EN 62304.

## Clinical Performance Data.

Not Applicable

# Conclusion as to Substantial Equivalence

The e3 Torque Control Motor is substantially equivalent to the X-Smart Easy (K092614) based on equivalence of the intended use, the non-clinical (11.092014) based on oqurvashovical characteristics. Performance testing data of performative cation and togino.orgistically and effectiveness of the X-Smart Easy. This included electrical safety, electromagnetic compatibility, and non-clinical performance testing of both hardware and software functions. The e3 Torque Control Motor does not raise any new issues of safety, effectiveness, or Forque Coma of the product when compared to the X-Smart Easy. These test performation of a determination of substantial equivalence.

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Image /page/3/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a stylized eagle or bird symbol, composed of three curved lines that suggest wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Ms. Helen Lewis Director Dentsply International, Incorporated 221 West Philadelphia Street, Suite 60 York, Pennsylvania 17404

MAY 2 6 2011

Re: K103653

Trade/Device Name: e3 Torque Control Motor Regulation Number: 21 CFR 872.4200 Regulation Name: Dental Handpiece and Accessories Regulatory Class: I Product Code: EBW Dated: May 19, 2011 Received: May19, 2011

Dear Ms. Lewis:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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. Lewis

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/MedicalDevices/Safety/ReportaProblem/default.htm 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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Susan Reins

Anthony D. Watson, B.S., M.S., M.B.A. 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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### SECTION 4. INDICATIONS FOR USE STATEMENT

510(k) Number (if known):

11/3653

Device Name: e3 Torque Control Motor

Indications for Use:

The e3 Torque Control Motor is a medical device designed for use by dentists for use with dental root canal instruments in continuous rotation with torque control or in reciprocating movement.

Prescription Use X (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)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Rumm

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K103653