SCALETRON PIEZO ULTRASOUND SCALER

K033120 · Pac-Dent International (Suzhou), Ltd. · ELC · Jan 29, 2004 · Dental

Device Facts

• Record ID: K033120
• Device Name: SCALETRON PIEZO ULTRASOUND SCALER
• Applicant: Pac-Dent International (Suzhou), Ltd.
• Product Code: ELC · Dental
• Decision Date: Jan 29, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4850
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Scaletron™ is a Piezo Ultrasonic Scaler intended for use in fast and reliable removal of light to heavy calculus deposits and stains from teeth.

Device Story

The ScaleTron is a piezo ultrasonic scaler used by dental professionals for the removal of calculus and stains from teeth. The device consists of a main unit with an integrated peristaltic water pump, a hose, a handpiece, and a foot control switch. It operates by generating linear tip movement at a nominal frequency of 30 kHz. The water pump provides irrigation during the scaling procedure. The clinician operates the device via the foot switch to activate the ultrasonic tip, which mechanically dislodges deposits from the tooth surface. The device is intended for use in a dental office environment.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Piezoelectric ultrasonic scaler; nominal frequency 30 kHz; includes peristaltic water pump, hose, handpiece, and foot control switch. Linear tip movement. Standalone dental device.

Indications for Use

Indicated for the removal of light to heavy calculus deposits and stains from teeth in a dental clinical setting.

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

• Deldent Ltd. Delsonic 2000TM (K014238)

Submission Summary (Full Text)

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# Pac-Dent International (Suzhou), Inc.

# KO33120

# 510(k) Summary of Safety and Effectiveness

#### Submitter:

Pac-Dent International (Suzhou), Inc. 125 Binhe Road, New District of Suzhou City, Jiangsu Province, P. R. China Phone: [phone] Fax: [phone] Contact Person: Xu Wang US Agent Daniel Wang Phone: [phone] Fax: [phone] Date Summary Prepared: Sep.2003

#### Device Name:

Trade Name: ScaleTron™ Piezo Ultrasonic Scaler Common Name: Piezo Ultrasonic Scaler Classification Name: Scaler, Ultrasonic Classification: Class II

#### Devices for Which Substantial Equivalence is Claimed:

Deldent Ltd. Delsonic 2000TM

## Device Description:

The Scaletron ™ consists of the main scaler unit (including a peristaltic water pump), a hose, a connector for handpiece and a foot control switch. It is designed to generate regular linear tip movement at nominal 30 KHz.

## Intended Use of the Device:

The Scaletron ™ is a Piezo Ultrasonic Scaler intended for use in fast and reliable removal of light to heavy calculus deposits and stains from teeth.

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## Substantial Equivalence:

Scaletron™ Piezo Ultrasonic Scaler is substantially equivalent to the other legally marketed devices in the United States. Scaletron™ Piezo Ultrasonic Scaler functions in a same manner and is intended for the same use as the Delsonic 2000™ Piezo Ultrasonic Scaler (K014238) designed by Deldent Ltd.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 2 9 2004

Pac-Dent International (SUZHOU), limited C/O Mr. Daniel Wang President Pac-Dent Interantional, Incorporated 21078 Commerce Pointe Drive Walnut, California 91789

Re: K033120

Trade/Device Name: SacleTron Piezo Ultrasonic Scaler Regulation Number: 21 CFR 872.4850 Regulation Name: Ulatrasonic Sacler Regulatory Class: II Product Code: ELC Dated: January 7, 2004 Received: January 8, 2004

Dear Mr. Wang:

We have reviewed your Section 510(k) promarket 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 adultcration.

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.

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Page 2 - Mr. Wang

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 nean that I any Federal statutes and regulations administered by other Federal agencies. or the Fet of any ly with all the Act's requirements, including, but not limited to: registration 1 ou 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 vour device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), r you acunted 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 vours.

Carl

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

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# Indications for Use

K033120 510(k) Number (if known):

Device Name: ScaleTron™ Piezo Ultrasonic Scaler

#### Indications for Use:

The Scaletron™ is a Piezo Ultrasonic Scaler intended for use in fast and reliable removal of light to heavy calculus deposits and stains from teeth.

Over-The-Counter Use AND/OR Prescription Use _____________________________________________________________________________________________________________________________________________________________ (21 CFR 807 Subpart C) (Part 21 CFR 801 Subpart D)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of ____________________________________________________________________________________________________________________________________________________________________

Susan Russo

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

510(k) Number: Ko 33120