(76 days)
No
The summary describes a standard ultrasonic scaler with basic controls (turbo mode, scaling/perio mode, water/power adjustment) and does not mention any AI or ML capabilities. The "Mentions AI, DNN, or ML" and "Description of the training set..." sections are explicitly marked as "Not Found".
No
The device is used to remove calculus deposits from teeth, which is a therapeutic intervention, but it is not classified as a therapeutic device in the traditional sense, as it does not actively treat a disease or condition in the body beyond cleaning.
No
The device is an ultrasonic scaler used for removing calculus deposits from teeth during dental cleaning and periodontal therapy, which are treatment procedures, not diagnostic ones. Its function is to clean teeth, not to identify or characterize medical conditions.
No
The device description clearly outlines hardware components such as a handpiece, footswitch, water adjustment, and power adjustment, indicating it is a physical medical device, not software-only.
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 deposits from teeth by application of an ultrasonic vibrating scaler tip to the teeth." This describes a physical intervention on the patient's teeth, not a test performed on a sample taken from the body to diagnose a condition.
- Device Description: The description details a physical device with a handpiece, tips, and controls for power and water. It doesn't mention any components or processes related to analyzing biological samples.
- Lack of IVD Indicators: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing diagnostic information about a disease or condition
- Using reagents or assays
In summary, the Bonart ART Ultrasonic Scaler is a therapeutic device used for a physical procedure on the patient, not a diagnostic device used to test samples.
N/A
Intended Use / Indications for Use
The BONART CO., LTD. ART Ultrasonic Scaler is intended for use during dental cleaning and periodontal therapy to remove calculus deposits from teeth by application of an ultrasonic vibrating scaler tip to the teeth.
Product codes
ELC
Device Description
The Bonart ART-P3 comes equipped with a turbo mode and can be operated in scaling or perio mode functions. The Bonart ART Ultrasonic Scaler ART-P3 is equipped with water adjustment and power adjustment. The unit is operated by a footswitch and comes complete with a handpiece. The handpiece is compatible with EMS ,SATELEC and Bonart tips.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
teeth
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
The Bonart ART Ultrasonic Scaler ART-P3 was subjected to performance bench testing in accordance with applicable industry and clinical standards. Physical performance studies were conducted to verify that the Bonart ART Ultrasonic Scaler ART-P3 conformed to all emission and immunity standards in accordance with EN and IEC regulations. Results of the testing showed that the Bonart ART Ultrasonic Scaler ART-P3 performs as intended.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
MAR - 6 2000
ART Ultrasonic Scaler ART-P3 Original Premarket 510(k) Notification
SUMMARY OF SAFETY AND EFFECTIVENESS SECTION 14:
This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and CFR 807.92.
14.1 SUBMITIER INFORMATION
14
| a. | Company Name: | BONART CO., LTD. |
|---|---|---|
| b. | Company Address: | RM.405, NO. 3 Wuchuan 1st Road, Sinchuan ,Taipei |
| Hsien, Taiwan. | ||
| C. | Company Phone: | 886-2-22983980 |
| Company Facsimile: | 886-2-22983981 | |
| d. | Contact Person: | Bankson Tsai |
| e. | Date Summary Prepared: | December 15, 1999 |
| 4.2. | DEVICE IDENTIFICATION | |
| a. | Trade/Proprietary Name: | ART Ultrasonic Scaler .ART-P3 |
| b. | Classification Name: | Ultrasonic Scaler |
| 21 CFR 872.4850 |
IDENTIFICATION OF PREDICATE DEVICE 14.3
| Company | Device | 510(k) No. | Date Cleared |
|---|---|---|---|
| SATELEC | SUPRASSON P5 Booster | K961158 | 05:23.96 |
| EMS. | MiniPiezo Ultrasonic Scaler | K953026 | 08/28/95 |
1
14.4 DEVICE DESCRIPTION
The Bonart ART-P3 comes equipped with a turbo mode and can be operated in scaling or perio mode functions. The Bonart ART Ultrasonic Scaler ART-P3 is equipped with water adjustment and power adjustment. The unit is operated by a footswitch and comes complete with a handpiece. The handpiece is compatible with EMS ,SATELEC and Bonart tips.
14.5 SUBSTANTIAL EQUIVALENCE
The Bonart ART Ultrasonic Scaler ART-P3 is substantially equivalent to the Suprasson P5 Booster in commercial distribution by SATELEC and to the miniPiezon Ultrasonic Scaler in commercial distribution by the EMS.
The fundamental technical characteristics of the Bonart ART Ultrasonic Scaler ART-P3 are similar to those of the predicate devices and are listed on the comparison charts provided in this 510(k) submission. The Bonart ART and the predicate devices function in the scaling modes. There are 30 kHz power output capabilities with the Bonart ART Ultrasonic Scaler ART-P3 and the predicate devices. Power and water adjustment features are present in all units.
14.6 INTENDED USE
The Bonart ART Ultrasonic Scaler is intended for use during dental cleaning and periodontal therapy to remove calculus deposits from teeth by application of an ultrasonic vibrating scaler tip to the teeth.
2
ART Ultrasonic Scaler ART-P3 Original Premarket 510(k) Notification
TECHNOLOGICAL CHARACTERISTICS 14.7
A comparison of the technological characteristics of the Bonart ART Ultrasonic Scaler ART-P3 with the predicate devices is provided within this submission. The Bonart ART Ultrasonic Scaler ART-P3 and the predicate devices are composed of a scaling unit, handpiece, footswitch and Tips. Both adjustable power outputs are available with the Bonart ART and the predicate devices. Turbo functions, and scaling modes are also common to each of the units.
14.8 PERFORMANCE DATA
The Bonart ART Ultrasonic Scaler ART-P3 was subjected to performance bench testing in accordance with applicable industry and clinical standards. Physical performance studies were conducted to verify that the Bonart ART Ultrasonic Scaler ART-P3 conformed to all emission and immunity standards in accordance with EN and IEC regulations. Results of the testing showed that the Bonart ART Ultrasonic Scaler ART-P3 performs as intended.
14.9 510(K) CHECKLIST
This notification contains all information required by 21 CFR 807.87. A completed copy of the Premarket Notification 510(k) Reviewer's Checklist is provided in this submission.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an emblem featuring a stylized caduceus, which is a symbol often associated with healthcare and medicine.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR - 6 2000
Mr. Bankson Tsai General Manager Bonart Co., Ltd. Room 405, No. 3 Wuchuan 1° Road Hsinchuanq, Taipei Hsien Taiwan
Re : K994299 Trade Name: ART Ultrasonic Scaler ART-P3 Regulatory Class: II Product Code: ELC December 15, 1999 Dated: Received: December 21, 1999
Dear Mr. Tsai:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in Please note: this response to your the Federal Register. premarket notification submission does not affect any obligation you might have under sections 531 through 542 of
4
Paqe 2 — Mr. Tsai
the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
This letter will allow you to begin marketing your device as described in your 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 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4690. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to
premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely
iy A. Ulatowski Timo Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
ART Ultrasonic Scaler ART-P3 Original Premarket 510(k) Notification
INDICATION FOR USE
510(k) Number :
To Be Assigned By FDA
Device Name:
BONART CO., LTD. ART Ultrasonic Scaler ART-P3
Indication for Use:
The BONART CO., LTD. ART Ultrasonic Scaler is intended for use during dental cleaning and periodontal therapy to remove calculus deposits from teeth by application of an ultrasonic vibrating scaler tip to the teeth.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Runno
vision Sign-C
Prescription Use
OR
Over-The-Counter Use
(Per 21 CFR 801.109)