CAVITRON RF ULTRASONIC SCALER SYSTEM WITH STERIMATE HANDPIECE, MODEL G-131

K052334 · Dentsply Intl. · ELC · Sep 2, 2005 · Dental

Device Facts

• Record ID: K052334
• Device Name: CAVITRON RF ULTRASONIC SCALER SYSTEM WITH STERIMATE HANDPIECE, MODEL G-131
• Applicant: Dentsply Intl.
• Product Code: ELC · Dental
• Decision Date: Sep 2, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 872.4850
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Used for ultrasonic procedures: 1) All general supra and subgingival scaling applications; 2) Debridement for all types of periodontal diseases; and 3) Endodontic procedures

Device Story

The Cavitron RF Ultrasonic Scaler System (Model G-131) is a dental device used for mechanical debridement of tartar. It consists of a base unit and a detachable, sterilizable Sterimate handpiece. The system generates an electromagnetic field pulsed at 30 kHz, which is transmitted to the handpiece. When a magnetostrictive insert is placed in the handpiece, it resonates at 30 kHz, causing the insert tip to vibrate in a reciprocal motion. The system includes a footswitch that communicates via an RF link or auxiliary hardwired cable to activate water flow (lavage) or ultrasonic energy. The device is operated by dental professionals in a clinical setting to perform scaling and endodontic procedures. By removing calculus and plaque, the device aids in the treatment of periodontal disease.

Clinical Evidence

Bench testing only.

Technological Characteristics

Magnetostrictive ultrasonic scaler; 30 kHz operating frequency; 100-240 VAC, 50-60 Hz power input; detachable Sterimate handpiece; RF or hardwired footswitch connectivity; controls for power (tip stroke) and lavage flow rates.

Indications for Use

Indicated for patients requiring general supra and subgingival scaling, periodontal disease debridement, and endodontic procedures.

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

• DENTSPLY Cavitron SPS Scaler System, Model G-119 (K970123)

Submission Summary (Full Text)

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K052334
510(k) SUMMARY

## SEP - 2 2005

DENTSPLY International Susquehanna Commerce Center West 221 West Philadelphia Street, Suite 60 York, PA 17405-0872

| CONTACT: | Helen Lewis |
|----------------------------|-------------------------------------------------------------------------------------------|
| DATE PREPARED: | August 23, 2005 |
| TRADE OR PROPRIETARY NAME: | Model G-131, CAVITRON ^® RF Ultrasonic Scaler System with Sterimate Handpiece |
| CLASSIFICATION NAME: | Ultrasonic scaler 872.4850 |
| PREDICATE DEVICES: | DENTSPLY Cavitron SPS Scaler System, Model G-119 (K970123) |

DEVICE DESCRIPTION: The Modified Device, the Model G131 consists of the Cavitron RF DE VIC E DESCRIPTION. The Product, and the applicable model families of Cavitron 30K Ultrasonic Inserts.

The Model G-131 Cavitron RF Utrasonic Scaler with Sterimate handpiece is a 30K ultrasonic The Model (1) 127 Carriros an electrical signal to the detachable, sterilizable handpiece. The dental device that provides an electroniagnetic field, pulsed at 30 kilohertz (KHz) through the length of the handpiece. When a magnetostrictive insert, designed to resonate near 30kHz is the length of the handpiece it will vibrate at the designed resonance which in turn excites the miserica mito and namapleed in reciprocal motion. The system operates over a frequency range working top, causing it to strent voltage of the Scaler is 100 - 240 VAC, 50 to 60 Hz

INTENDED USE: Used for ultrasonic procedures: 1) All general supra and subgingival scaling INTEATED OFF. OSC 10/ USC 10/ Childement for all types of periodontal diseases; and 3) Endodontic procedures

TECHNOLOGICAL CHARACTERISTICS: The Cavitron RF magnetostrictive ultrasonic TECTINOENON AT - OHARA - EFRE rounter top use to mechanically debride (remove tartar) Scanny system is a dovree intention system drives an ultrasonic insert designed with a resonate from numan deather. The seating by and in the distal end of the insert tip. The trequency wouldes a means for control of power (tip stroke) and lavage flow rates. The system is system provides a means for comrer minicates through a RF link or through an auxillary hardwired cable. The footswitch has two positions which activates a water solenoid or ultrasonic energy to the handpiece.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized human figure with three flowing lines representing the body and arms.

Public Health Service

SEP - 2 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Helen Lewis Mis. Helen Bowls
Director of Corporate Compliance and Regulatory Affairs Susquehanna Commerce Center West 221 West Philadelphia Street York, Pennsylvania 17404

Re: K052334

Trade/Device Name: Cavitron RF Ultrasonic Scaler System with Sterimate Handpiece Regulation Number: 21 CFR 872.4850 Regulation Name: Ultrasonic scaler Regulatory Class: II Product Code: ELC Dated: August 23, 2005 Received: August 26, 2005

Dear Ms. Lewis:

We have reviewed your Section 510(k) premarket notification of intent to market the devices We have reviewed your Section 910(x) premainer's substantially equivalent (for the indications referenced above and nave decembined the marketed predicate devices marketed in interstate for use stated in the encrosule for regary maneted povice Amendments, or to
commerce prior to May 28, 1976, the enactment date of the Medical Forley of Food. Fored Freed, Dry commerce prior to May 20, 1976, the encordance with the provisions of the Federal Food. Drug. devices that have been reclassified in acceraance was a premarket approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a premarket approval or o and Cosment Act (Act) that do not requent appen o the general controls provisions of the Act. The You may, merelore, market the devree, basjeer to the see annual registration, listing of general controls provisions of the free head. I see in the more of the misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classifica (sec above) into exist in the subscriptions affecting your device can
may be subject to such additional controls. Existing major regulations ED may be subject to such additional controller Entibility of Controller. be found in the Code of Peaces oncerning 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 Please be advised that FDA \$ issualles of a substition on the requirements of the Act
that FDA has made a determination that your device complies . You must that FDA has made a decemination that your as roos of her Federal agencies. You must and list or any Federal statules and regulations daministers. by registration and listing (21
comply with all the Act's requirements, including, but not limited to set comply with all the Act s requirements, moradial ware and one of the requirements as set
CFR Part 807); labeling (21 CFR Part 801); good manufacturing as and CFR Part 807); labeling (21 CFR Part 800); good and if applicable, the electronic
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the elect forth in the quality systems (Sections (Sections 531-542 of the Act); 21 CFR 1000-1050.
product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050 product radiation control provisions (Sections of Perice as described in your Section 510(k)
This letter will allow you to begin marketing your device of your daying to legal This letter will anow you to ocgin mancemig of substantial equivalence of your device to a legally premarket notification. The FDA midnig of substantial equives 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
rs the received in the most of 115 at the couls to reculption entitled If you desire specific advice for your de not on our said the regulation entitled, they may obtain contact the Office of Complaned at [phone]" (21CFR Part 807.97). You may obtain " Misbranding by relevelec to premarket notificalled in the Act from the Division of Small other general information on your responsible the toll-free number [phone] or
Manufacturers, International and Consumer Assistance at and Cincludes attindex attack Manufacturers, International and Colisanier Fishows.cda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Michie Oms.

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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Image /page/3/Picture/0 description: The image shows the text "K052334" in a handwritten style. The text is underlined. Below the line is the text "INDICATIONS FOR USE STATEMENT".

510(K) Number (if known):

## Device Name: Model G-131, CAVITRON® RF ULTRASONIS SCALER SYSTEM
PRODUCTION CONSECTED CATE HANDRIECE WITH STERIMATE HANDPIECE

Indications for Use:

Used for ultrasonic procedures:

- All general supra and subgingival scaling applications .
- An general supra ament for all types of periodontal diseases .
- Endodontic procedures .

Prescription Use _ _______ (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)

Susan Suarez

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

510(k) Number: K052334