ULTRASONIC SCALER

K113717 · Nakanishi, Inc. · ELC · Mar 5, 2013 · Dental

Device Facts

• Record ID: K113717
• Device Name: ULTRASONIC SCALER
• Applicant: Nakanishi, Inc.
• Product Code: ELC · Dental
• Decision Date: Mar 5, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4850
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

This product is intended only for dental clinic /dental office use. This device generates ultrasonic waves intended for use in dental applications such as scaling, root canal treatment, periodontal and cavity preparation.

Device Story

Varios 370 / Varios 370 Lux is a compact, portable ultrasonic scaler for dental clinic use. Device utilizes iPiezo engine to generate sinusoidal electrical signals (28-32 KHz); signals delivered to piezoelectric ceramic within handpiece transducer; converted into mechanical vibrations at tip. Varios 370 Lux includes twin LED lights for improved visualization. Operated by dental professionals. Output consists of ultrasonic mechanical vibrations for scaling, root canal, periodontal, and cavity preparation procedures. Benefits include efficient removal of dental deposits and preparation of tooth structures.

Clinical Evidence

Bench testing only. Device validated for electrical safety (IEC 60601-1, UL 60601-1), electromagnetic compatibility (IEC 60601-1-2), biocompatibility (ISO 10993-1), and dental handpiece performance (ISO 22374). Software validation performed per FDA guidance.

Technological Characteristics

Compact, portable control unit; iPiezo engine; piezoelectric ceramic transducer; ultrasonic frequency 28-32 KHz; twin LED lights (Lux model). Standards: IEC 60601-1 (electrical safety), IEC 60601-1-2 (EMC), ISO 10993-1 (biocompatibility), ISO 22374 (dental handpieces), AAMI/ANSI/ISO 17665-1 (moist heat sterilization).

Indications for Use

Indicated for use in dental clinics/offices for dental procedures including scaling, root canal treatment, periodontal treatment, and cavity preparation.

Regulatory Classification

Identification

An ultrasonic scaler is a device intended for use during dental cleaning and periodontal (gum) therapy to remove calculus deposits from teeth by application of an ultrasonic vibrating scaler tip to the teeth.

Predicate Devices

• Nakanishi Varios 350 / Varios 350 Lux (K031421)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo for NSK, a Japanese manufacturer of bearings. The logo is white and is set against a black background. The letters "NSK" are in a bold, sans-serif font. There is a horizontal line above the letters.

ド || 3717

" 5. 510(k) SUMMARY

| Submitter: | Nakanishi, Inc.<br>700 Shimohinata<br>Kanuma-Shi, Tochigi-Ken Japan 322-8666 | MAR 0 5 2013 |
|-------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| Contact Person: | Mr. Toshihiko Shinozaki<br>Assistant Manager, R&D Dept. Pharmaceutical Affairs Gr.<br>TEL: [phone]<br>FAX: [phone]<br>[e-mail] | |
| Date Prepared: | March 5, 2013 | |
| Trade Name: | Varios 370 / Varios 370 Lux | |
| Common Name: | Ultrasonic Scaler | |
| Classification Name: | ELC 872.4850 Scaler, Ultrasonic | |
| Predicate Device: | K031421 – Nakanishi Varios 350 / Varios 350 Lux | |
| Device Description: | The Varios 370 is a compact, portable control unit powered by the iPiezo® engine.<br>The product comes with a wide range of tip inserts, which can be attached at the<br>distal end of the Varios 2 Handpiece transducer and vibrates at ultrasonic<br>frequencies of 28 to 32 KHz.<br>The Varios 370 LUX features twin LED lights, assuring generally clearer vision<br>and easier identification of the treatment area. | |
| Statement of<br>Intended Use: | This product is intended only for dental clinic /dental office use. This device<br>generates ultrasonic waves intended for use in dental applications such as scaling,<br>root canal treatment, periodontal and cavity preparation. | |
| Summary of<br>Technological<br>Characteristics: | The Varios 370 is a compact, portable control unit, allowing easy installation into<br>any dental unit, and powered by the iPiezo® engine. During the mode of operation, a<br>sinusoidal electrical signal, at ultrasonic frequency (f > 20Khz), is generated and<br>delivered to the 'piezoelectric ceramic' located inside the handpiece transducer. The<br>electrical signal is converted into mechanical vibrations and propagated to the distal<br>end of the handpiece. | |
| Summary of<br>Testing: | As required by 21 CFR 820.30(g), the Varios 370 has been successfully subjected to design validation, including software validation. Software validation documentation was provided in compliance with FDA document Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.<br><br>In addition, the Varios 370 has been successfully tested in accordance with the following applicable standards for medical devices:<br>Electrical Safety: IEC 60601-1 (Medical electrical equipment – Part 1: General requirements for basic safety and essential performance) Electrical Safety: UL 60601-1 (Medical Electrical Equipment – Part 1: General Requirements for Safety) | |

Image /page/0/Picture/4 description: This image shows the header of a document. It indicates that it is "Section 5: Page 1 of 2". It also includes the company name "NAKANISHI INC." along with their headquarters address: 700 Shimohihata Kanuma-shi Tochigi 322-8666, Japan. The Tokyo office address is also listed as MY Building 1-13-3 Ueno Taito-ku Tokyo 110-0005, Japan.

Image /page/0/Picture/5 description: The image shows a black and white drawing of a bird in flight. The bird has long, pointed wings and a long tail. The bird's body is slender and streamlined. The bird is flying against a white background. The words "Powerful Partner" are written in small font below the bird.

www.nsk-inc.com

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Image /page/1/Picture/0 description: The image shows the logo for NSK, a Japanese manufacturer of bearings. The logo is white and features the letters "NSK" in a bold, sans-serif font. A horizontal line is placed above the letters, adding a distinctive element to the design. The logo appears to be slightly distressed, giving it a textured look.

- Electromagnetic Compatibility: IEC 60601-1-2 (General requirements for . basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests}
- Biocompatibility: ISO 10993-1 (Biological evaluation of medical devices -. Part 1: Evaluation and testing)
- Dentistry: ISO 22374 (Dental handpieces Electrical-powered scalers and . scaler tips)
- Sterilization: AAMI/ANSI/ISO 17665-1 (Sterilization of health care . products - Moist heat - Part 1: Requirements for the development, validation, and routine control of a sterilization process for medical devices)

#### Conclusion:

Nakanishi, Inc. considers the Varios 370 Ultrasonic Scaler to be substantially equivalent to the predicate device listed above. This conclusion is based on the similarities in primary intended use, principles of operation, design rationale, test results, and performance.

Image /page/1/Picture/7 description: The image shows a logo with a black silhouette of a person's hand holding a pen or stylus over a tablet or similar device. The hand and device are positioned diagonally across the frame. Below the image is the text "Powerful Partner" in a smaller font size.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

#### March 5, 2013

Nakanishi, Incorporated C/O Ms. Diane Rutherford Regulatory Engineer Ken Block Consulting 1201 Richardson Drive, Suite 280 RICHARDSON TX 75080

Re: K113717

Trade/Device Name: Varios 370 / Varios 370 Lux Regulation Number: 21 CFR 872.4850 Regulation Name: Ultrasonic Scaler Regulatory Class: II Product Code: ELC Dated: February 15, 2013 Received: February 19, 2013

### Dear Ms. Rutherford:

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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# INDICATIONS FOR USE

### KII3717 510(k) Number:

Device Name: Varios 370 / Varios 370 Lux

Indications for Use:

This product is intended only for dental clinic /dental office use. This device generates ultrasonic waves intended for use in dental applications such as scaling, root canal treatment, periodontal and cavity preparation.

Prescription Use X (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 CDHR, Office of Device Evaluation (ODE)

Mary S Runner -2013.03.05
15:23:53 -05.00 ANA ನ್ನು ಸ

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

510(k) Number:

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