J. MORITA AZ ULTRASONIC SYSTEM

K053030 · J. Morita USA, Inc. · ELC · Nov 7, 2005 · Dental

Device Facts

• Record ID: K053030
• Device Name: J. MORITA AZ ULTRASONIC SYSTEM
• Applicant: J. Morita USA, Inc.
• Product Code: ELC · Dental
• Decision Date: Nov 7, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4850
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The AZ Ultrasonic System is an Ultra Scaler intended for use with an appropriate tip for Periodontic, Endodontic, Scaling and Ultra (Prosthesis) use.

Device Story

AZ Ultrasonic System is a dental ultrasonic scaler; utilizes ultrasonic energy to drive specialized tips for periodontic, endodontic, scaling, and prosthetic applications. Operated by dental professionals in clinical settings. Device transforms electrical energy into mechanical vibrations at the tip to remove calculus, plaque, or perform root canal procedures. Output is mechanical oscillation of the tip; affects clinical decision-making by enabling non-surgical periodontal therapy and endodontic cleaning. Benefits patient by facilitating minimally invasive dental hygiene and restorative preparation.

Clinical Evidence

Bench testing only.

Technological Characteristics

Ultrasonic scaler; utilizes ultrasonic energy for tip oscillation; intended for dental use; class II device; product code ELC.

Indications for Use

Indicated for dental patients requiring periodontic, endodontic, scaling, and prosthetic procedures using an ultrasonic scaler.

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.

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized image of an eagle with three lines representing its wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle image. The text is in all capital letters.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV - 7 2005

Mr. Howard Rowe Quality Systems Consultant J. Morita USA, Incorporated 9 Mason Irvine, California 92618

Re: K053030

Trade/Device Name: AZ Ultrasonic System Regulation Number: 21 CFR 872.4850 Regulation Name: Ultrasonic Scaler Regulatory Class: II Product Code: ELC Dated: October 26, 2005 Received: October 27, 2005

Dear Mr. Rowe:

We have reviewed your Section 510(k) premarket notification of intent to market the device w one re rewse 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 as or 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 nate beth 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 such 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 Eederal Register.

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Page 2 - Mr. Howard Rowe

Please be advised that FDA's issuance of a substantial equivalence determination does not mean r that FDA has made a determination that your device complies with other requirements of the Act or that F Dri has mude a acternalations 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); lan the Act of equirements) ; 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) I ms letter will and in your he FDA finding of substantial equivalence of your device to a legally premated predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). 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 yours,

signature

Chiu S. Lin, PhD 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

| 510(k) Number (if known): | Not Assigned to date K053030 |
|---------------------------|------------------------------|
|---------------------------|------------------------------|

Device Name:

AZ Ultrasonic System_

Indications For Use:

The AZ Ultrasonic System is an Ultra Scaler intended for use with an appropriate tip for Periodontic, Endodontic, Scaling and Ultra (Prosthesis) use.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use | X | OR | Over-The-Counter Use |
|------------------|---|----|----------------------|
|------------------|---|----|----------------------|

(Per 21 CFR 801.109)

Ken Mulay for MSR

(Print Sign-Off)

Division of Anesthesiology, General Hospital,

Infection Control, Dental Devices

K053030