(100 days)
ART-P6 Piczo Electric Ultrasonic Scaler is intended for use by medical professionals during dental cleaning and periodontal therapy to remove calculus and tartar deposits and stains from teeth using the application of an ultrasonically vibrating frequency through a stainless steel tip dental accessory called "Tip". Tip comes in various shapes (BS1, BS2, BS3 etc.) and is designed to generate a vibrating frequency of 29Khz,
BONART ART-P6 PIEZO ELECTRIC ULTRASONIC SCALER & ACCESSORIES (TIPS)
This document is a 510(k) premarket notification letter from the FDA regarding the Bonart Art-P6 Piezo Electric Ultrasonic Scaler & Accessories (Tips). It does not contain information about acceptance criteria, device performance studies, or ground truth establishment.
Therefore, I cannot provide the requested information. The letter only states that the device is substantially equivalent to legally marketed predicate devices, allowing it to be marketed. It does not include details of performance testing or clinical studies that would be necessary to answer your questions.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 2 6 2007
Bonart Company, Limited C/O Mr. Eric L. Ong Sales Manager Bonart Medical Technology, Incorporated 398 S. Lemon Creek Drive, Suite L Walnut, California 91789
Re: K071981
Trade/Device Name: Bonart Art-P6 Piezo Electric Ultrasonic Scaler & Accessories (Tips) Regulation Number: 21 CFR 872.4850 Regulation Name: Ultrasonic Scaler Regulatory Class: II Product Code: ELC Dated: October 19, 2007 Received: October 22, 2007
Dear Mr. Ong:
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.
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Page 2 - Mr. Ong
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 (240) 276-0115. 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Neil R.P. Ogden
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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INDICATION FOR USE
Applicant: Bonart Co., Ltd. Rm 405, No.3 Wuchuan 1st Road Hsinchuang, Taipei Usien, Taiwan, R.O.C. FDA Registration Number: 9710363
510(k) Number: To be assigned by FDA
BONART ART-P6 PIEZO ELECTRIC ULTRASONIC SCALER & Device Name: ACCESSORIES (TIPS)
ART-P6 Piczo Electric Ultrasonic Scaler is intended for use by medical Indication for Use: professionals during dental cleaning and periodontal therapy to remove calculus and tartar deposits and stains from teeth using the application of an ultrasonically vibrating frequency through a stainless steel tip dental accessory called "Tip". Tip comes in various shapes (BS1, BS2, BS3 etc.) and is designed to generate a vibrating frequency of 29Khz,
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Runne
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K071981
Original 510 (k) Submission Bomart Co., Lid. FDA Reg. No .: 9710363 Device Name/Model: AK1-P6 Piezo Llectric Scaler 1
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§ 872.4850 Ultrasonic scaler.
(a)
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.(b)
Classification. Class II.