X-SMART EASY

K092614 · Dentsply Interntional · EKX · Dec 2, 2009 · Dental

Device Facts

• Record ID: K092614
• Device Name: X-SMART EASY
• Applicant: Dentsply Interntional
• Product Code: EKX · Dental
• Decision Date: Dec 2, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4200
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

X-Smart Easy is indicated for use by dentists in standard endodontic procedures using rotary endodontic files and rotary endodontic drills (Gates-Glidden).

Device Story

X-Smart Easy is an electric motor-driven handpiece for root canal preparation. Operated by dentists in clinical settings, it powers rotary endodontic files and drills to facilitate endodontic procedures. The device transforms electrical energy into mechanical rotation to assist in cleaning and shaping root canals. It is used as a tool for the clinician to perform standard endodontic tasks, potentially improving procedural efficiency and patient outcomes during root canal therapy.

Clinical Evidence

No clinical data. Bench testing only, including biocompatibility (ISO 10993), electrical safety (UL60601-1), and electromagnetic compatibility (IEC 60601-1-2, IEC 61000-3-2).

Technological Characteristics

Electric motor-driven handpiece. Patient contact components meet biocompatibility standards. Conforms to UL60601-1, IEC 60601-1-2, and IEC 61000-3-2. Includes hardware and software components.

Indications for Use

Indicated for use by dentists performing standard endodontic procedures using rotary endodontic files and rotary endodontic drills (Gates-Glidden).

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

• Prophy-Mate and Endo Mate Motor Handpiece (K990682)

Submission Summary (Full Text)

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# K092614

# DENTSPLY International

World Headquarters Susquehanna Commerce Center 221 West Philadelphia Street York, PA 17405-0872 [phone] {voice} [phone] (fax) www.dentsply.com

DEC - 2 2009

## 510(k) Summary for X-Smart Easy

- 1. Submitter Information: 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:

18 August 2009

- Device Name: 2.
Proprietary Name: X-Smart Easy Classification Name: Dental Handpiece and Accessories 872.4200 CFR Number: Device Class: I EKX Product Code:

- 3. Predicate Device: Prophy-Mate and Endo Mate Motor Handpiece (K990682)
- Description of Device: 4. The X-Smart Easy is an electric motor-driven handpiece intended for root canal preparation procedures in endodontic industry.
- న్. Indications for Use:

X-Smart Easy is designed for use by dentists in standard endodontic procedures using rotary endodontic files and rotary endodontic drills (Gates-Glidden).

- Description of Safety and Substantial Equivalence 6.
## Technological Characteristics

Patient contact elements of the components found in X-Smart Easy have been used in legally marketed devices and/or were found safe for dental use.

DENTSPLY International | X-Smart Easy 18 August 2009

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## Non-Clinical Performance

Biocompatibility Testing

Cytotoxicity, sensitization and irritation testing were performed in accordance with ISO 10993. All patient contact components demonstrated biocompatibility.

### Electromagnetic Compatibility and Electrical Safetv

The X-Smart East conforms to UL60601-1 Medical Electrical Equipment, Part 1: General Requirements for Safety; IEC 60601-1-2 Medical Electrical Equipment, Part 1-2: General Requirements for Safety Collateral Standard Electromagnetic Compatibility; and IEC 61000-3-2 Electromagnetic Compatibility (EMC) Part 3: Limits - Section 3: Limitations of Voltage Fluctuations.

### Conclusion as to Substantial Equivalence

The X-Smart Easy is substantially equivalent to the Prophy Mate and Endo Mate Handpiece (K990682) based on equivalence of the intended use, similar features and technical characteristics. Performance testing was performed to validate the safety and effectiveness of the X-Smart Easy, which included electrical safety, electromagnetic compatibility, and validation testing of both hardware and software functions. The X-Smart Easy does not raise any new issues of safety, effectiveness, or performance of the product.

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

Ms. Helen Lewis Director DENTSPLY International Susquehanna Commerce Center 221 West Philadelphia Street, Suite 60 York, Pennsylvania 17404

DEC - 2 2009

Re: K092614 Trade/Device Name: X-Smart Easy Regulation Number: 21CFR 872.4200 Regulation Name: Dental Handpiece and Accessories Regulatory Class: I Product Code: EKX Dated: November 24, 2009 Received: November 25, 2009

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.

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,

for

Susan Runner, D.D.S., M.A. Acting Division 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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## Indications for Use Statement

1092614 510(k) Number (if known):

Device Name: X-Smart Easy

Indications for Use:

X-Smart Easy is indicated for use by dentists in standard endodontic procedures using rotary endodontic files and rotary endodontic drills (Gates-Glidden).

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)

Kain Hurley for NSR

(Division Sign-Off) (Division Sign-On)
Division of Anesthesiology, General Hospital Division of Andelhoental Devices

510(k) Number: