ULTRASONIC SCALER, MODELS VARIOS 350 LUX, VARIOS 350 (NO LIGHT), VARIOS 550, VARIOS 150 LUX, VARIOS 150 (NO LIGHT)

K031421 · Nakanishi, Inc. · ELC · Mar 26, 2004 · Dental

Device Facts

• Record ID: K031421
• Device Name: ULTRASONIC SCALER, MODELS VARIOS 350 LUX, VARIOS 350 (NO LIGHT), VARIOS 550, VARIOS 150 LUX, VARIOS 150 (NO LIGHT)
• Applicant: Nakanishi, Inc.
• Product Code: ELC · Dental
• Decision Date: Mar 26, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4850
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

These devices are ultrasonic scalers, intended for use with an appropriate tip for scaling, crown removal, amalgam condensation, excavating, periodontal, and endodontic use.

Device Story

Varios Model 350, 350 Lux, 150, 150 Lux, and 550 are ultrasonic scalers. Devices utilize ultrasonic energy to drive specialized tips for dental procedures including scaling, crown removal, amalgam condensation, excavation, periodontal, and endodontic treatments. Operated by dental professionals in clinical settings. Output is mechanical vibration of the tip to perform dental tasks. Benefits include efficient removal of calculus and debris, and facilitation of various restorative and endodontic procedures.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Ultrasonic scaler; electrical energy source; handheld form factor with interchangeable tips; intended for dental use.

Indications for Use

Indicated for dental patients requiring scaling, crown removal, amalgam condensation, excavation, periodontal, or endodontic procedures. Used by dental professionals.

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)

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three streams emanating from its body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the eagle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 6 2004

Nakanishi, Incorporated C/O Mr. Hiroji Sekiguchi Official Correspondents NSK America Corporation 700B Cooper Court Schaumburg, Illinois 60173

Re: K031421

Trade/Device Name: Varios Model 350, Model 350 Lux, Model 150, Model 150 Lux, Model 550 Regulation Number: 872.4850 Regulation Name: Ultrasonic Scaler Regulatory Class: II Product Code: ELC Dated: February 12, 2004 Received: February 17, 2004

Dear Mr. Sekiguchi:

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 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 Federal Register.

{1}------------------------------------------------

## Page 2 - Mr. Sekiguchi

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); 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) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed 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" (21CFR 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/dsma/dsmamain.html

Sincerely yours,

Chiu Lin, Ph.D.

Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

K03/421

## K031421

## Indications for Use Statement

510(k) Number (if known): K031421

Device Name: Varios Model 350, Model 350 Lux, Model 150, Model 150 Lux, Model ર રેણ

Indications For Use: These devices are ultrasonic scalers, intended for use with an appropriate tip for scaling, crown removal, amalgam condensation, excavating, periodontal, and endodontic use.

Prescription Use ਨ (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Sura Kumar

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

510(k) Number: K083146

Page 1 of ____________________________________________________________________________________________________________________________________________________________________