(86 days)
ART-P31! Pro Multi-function piezoelectric Ultrasonic system is intended for use by medical professionals during denral 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 t p dental accessory called "Tip". Tip comes in various shapes (BS1, BS2, B53 etc.) and is designed to generate a vibrating frequency of 29Khz.
ART-M311 Pro Multi-function-Magnet Ultrasonic System is intended for use by medical professionals during demal 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 "Insert comes in various shapes (ART P-10, ART SLI-P100, ART IF50 etc.) and is designed to generate a vibrating frequency of 24.5KHz. ±5%.
Not Found
The provided document is a 510(k) premarket notification letter from the FDA for a dental ultrasonic scaler. It states that the device is substantially equivalent to legally marketed predicate devices. However, this document does not contain the information requested regarding acceptance criteria and the study that proves the device meets those criteria.
Specifically, the document does not include:
- A table of acceptance criteria and reported device performance.
- Sample sizes or data provenance for any test sets.
- Number or qualifications of experts used for ground truth.
- Adjudication methods.
- Information about a multi-reader multi-case (MRMC) comparative effectiveness study or related effect sizes.
- Information about standalone algorithm performance.
- The type of ground truth used (e.g., pathology, outcomes data).
- Sample size for the training set.
- How ground truth for the training set was established.
This document is a regulatory approval letter based on substantial equivalence to predicate devices, not a detailed report of performance studies against specific acceptance criteria.
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Image /page/0/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" arranged around the top half of the circle. The bottom half of the circle is blank. In the center of the circle is a stylized image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 2 8 2008
Bonart Company, Limited C/O Mr. Eric L. Ong Sales and Operations Manager Bonart Medical Technology Incorporated 398 South Lemon Creek Drive, Suite L Walnut, California 91789
Re: K081550
Trade/Device Names: Bonart-ART-P3II Multi-Function Piezoelectric Ultrasonic System wit Accessories (Tips) Bonart ART-M3II Multi-Function Magnet Ultrasonic System with Accessories (Inserts) Regulation Number: 21 CFR 872.4850 Regulation Name: Ultrasonic Scaler
Regulatory Class: II Product Code: ELC Dated: May 29, 2008
Received: June 3, 2008
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
VK Amelie-Kendry
for 4
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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Ko81550
INDICATION FOR USE
Bonart Co., Ltd. Applicant: Rm.405, No.3 Wuchuan 18 Road Hsinchuang, Taipei Hsien, Taiwan, R.O.C. (China) FDA Registration Number: 9710363
510(k) Number: To be assigned by FDA
Device Name: Bonart ART-P311 Multi-Function Piezoelectric Ultrasonic system with accessories (tips) Bonart ART-M311 Multi-Function Magnet Ultrasonic system with accessories (inserts)
Indication for Use:
ART-P31! Pro Multi-function piezoelectric Ultrasonic system is intended for use by medical professionals during denral 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 t p dental accessory called "Tip". Tip comes in various shapes (BS1, BS2, B53 etc.) and is designed to generate a vibrating frequency of 29Khz.
ART-M311 Pro Multi-function-Magnet Ultrasonic System is intended for use by medical professionals during demal 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 "Insert comes in various shapes (ART P-10, ART SLI-P100, ART IF50 etc.) and is designed to generate a vibrating frequency of 24.5KHz. ±5%. .
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
B. Bote DDS for Dr. Runner
(Division Sign Off)
Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K08/550
Concurrence of CDRH, Office of Device Evaluation (ODE)
§ 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.