(87 days)
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No
The 510(k) summary describes a standard ultrasonic scaler and does not mention any AI or ML components or functionalities.
Yes
The device is described as an ultrasonic scaler used by medical professionals during dental cleaning and periodontal therapy to remove calculus, tartar deposits, and stains from teeth, which aligns with the definition of a therapeutic device as it directly treats a condition (deposits/stains on teeth).
No
Explanation: The device is described as an ultrasonic scaler used for cleaning teeth by removing calculus, tartar deposits, and stains. Its function is therapeutic (dental cleaning), not diagnostic.
No
The device description clearly identifies the device as a "Piezo Ultrasonic Scaler" and mentions "Tips" as accessories, indicating a physical hardware device used for dental procedures.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for dental cleaning and periodontal therapy to remove calculus, tartar, and stains from teeth. This is a therapeutic and procedural use, not a diagnostic one.
- Mechanism of Action: The device uses ultrasonic vibrations to physically remove deposits from teeth. This is a mechanical action performed directly on the patient's teeth, not an analysis of a sample taken from the body.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (like blood, urine, tissue, etc.) or providing diagnostic information about a patient's health condition.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
BONART's ART-P3II & ART-P4 Piezo Ultrasonic Scaler are 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". Tips come in various shapes (BS1, BS2, BS3 etc.) and are designed to generate a vibrating frequency of 29Khz.
Product codes
ELC
Device Description
BONART ART-P3II PIEZO ULTRASONIC SCALER & ACCESSORIES (TIPS)
BONART ART-P4 PIEZO ULTRASONIC SCALER & ACCESSORIES (TIPS)
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
teeth
Indicated Patient Age Range
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Intended User / Care Setting
medical professionals
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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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.
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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health and Human Services, USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" arranged around the perimeter. Inside the circle is a stylized graphic of an eagle or bird-like figure with three curved lines representing its wings or feathers.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 1 7 2006
Bonart Company, Limited C/O Mr. Eric L. Ong Sales Manager Bonart Medical Technology, Incorporated 398 South Lemon Creek Drive, Suite L Walnut, California 91789
Re: K061448
Trade/Device Name: Bonart ART-P3II Piezo Ultrasonic Scaler & Accessories (Tips) Bonart ART-P4 Piezo Ultrasonic Scaler & Accessories (Tips) Regulation Number: 872.4850 Regulation Name: Ultrasonic Scaler Regulatory Class: II Product Code: ELC Dated: May 18, 2006 Received: May 22, 2006
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, thereforc, 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 vour 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 yours,
Chin Lin, Ph.D.
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
510(k) Number (if known): To be Assigned by FDA
Device Name: BONART ART-P3II PIEZO ULTRASONIC SCALER & ACCESSORIES (TIPS) BONART ART-P4 PIEZO ULTRASONIC SCALER & ACCESSORIES (TIPS)
Indications for Use:
BONART's ART-P3II & ART-P4 Piezo Ultrasonic Scaler are 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". Tips come in various shapes (BS1, BS2, BS3 etc.) and are designed to generate a vibrating frequency of 29Khz.
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 OF NEEDED)
on-(Off)
Anesthesiology, General Hospical, on Control, Dental Devices
Number. K061448
Original 510(k) Submission Bonart Co., Ltd. FDA Reg. No.9710363 Bonart Co., Ltd. FDA Reg. No.7710565
Device Name/Model: ART-P3II &P4 Ultrasonic Scaler w/Accessories