JETSONIC 2000

K014245 · Deldent , Ltd. · KOJ · Jan 29, 2002 · Dental

Device Facts

• Record ID: K014245
• Device Name: JETSONIC 2000
• Applicant: Deldent , Ltd.
• Product Code: KOJ · Dental
• Decision Date: Jan 29, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.6080
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The JETSONIC 2000 combines both scaling and airpolishing functions in one The 62100110 2000 wers all prophylaxis needs. The airpolishing function is intended to be used to remove stubborn stains, plaque and soft debris. The scaler michaed to be used to be used for for fast and reliable removal of light to heavy calculus and plaque. Carculus and plaque. Device applications: Routine oral prophylaxis , routine polishing especially hard to Device applications. It enamel etching and bonding techniques and prior to bonding orthodontic bands and brackets

Device Story

JetSonic 2000 is a dental prophylaxis unit combining scaling and air-polishing functions. Device removes stains, plaque, soft debris, and calculus from tooth surfaces. Used by dental professionals in clinical settings for routine cleaning, enamel etching, and orthodontic preparation. Operates via mechanical scaling and air-polishing mechanisms to facilitate dental hygiene and restorative procedures.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Combined scaler and air-polishing unit. Class II device (Product Code: KOJ). Mechanical/pneumatic operation for dental prophylaxis.

Indications for Use

Indicated for routine oral prophylaxis, removal of stubborn stains, plaque, soft debris, and light to heavy calculus. Used for enamel etching, bonding techniques, and preparation for orthodontic bands and brackets.

Regulatory Classification

Identification

An airbrush is an AC-powered device intended for use in conjunction with articulation paper. The device uses air-driven particles to roughen the surfaces of dental restorations. Uneven areas of the restorations are then identified by use of articulation paper.

Special Controls

The special control for this device is International Electrotechnical Commission's IEC 60601-1-AM2 (1995-03), Amendment 2, “Medical Electrical Equipment—Part 1: General Requirements for Safety.”

Submission Summary (Full Text)

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Image /page/0/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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, depicted with three stylized wing segments and flowing tail feathers.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 2 9 2002

Mr. Alan Edel Regulatory Affairs Manager Deldent Limited 19 Keren Kayement Street Petach Tikvah, ISRAEL

Re: K014245

Trade/Device Name: JetSonic 2000 Regulation Number: 872.6080 Regulation Name: Scaler & Airpolishing Unit Regulatory Class: II Product Code: KOJ Dated: November 27, 2001 Received: December 26, 2001

Dear Mr. Edel:

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.

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

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Page 2 - Mr. Edel

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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,

Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

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## KO14245

## LABELING

Page 1 of 1

510(k) Number (if known): Unknown

Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications for Use:

The JETSONIC 2000 combines both scaling and airpolishing functions in one The 62100110 2000 wers all prophylaxis needs. The airpolishing function is intended to be used to remove stubborn stains, plaque and soft debris. The scaler michaed to be used to be used for for fast and reliable removal of light to heavy calculus and plaque.

Carculus and plaque.
Device applications: Routine oral prophylaxis , routine polishing especially hard to Device applications. It enamel etching and bonding techniques and prior to bonding orthodontic bands and brackets

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

Concurrence of CDRH, Office of Device Evaluation (ODE) Over-The-Counter Use OR Prescription Use_ (Optional Format 1-2-96) Per 21 CFR801.109) Support

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