ART-M3 25K, MODEL M3-1-ART2-A1; ART-M3 30K, MODEL M3-1-ART3-A1

K994203 · Bonart Co., Ltd. · ELC · Mar 6, 2000 · Dental

Device Facts

• Record ID: K994203
• Device Name: ART-M3 25K, MODEL M3-1-ART2-A1; ART-M3 30K, MODEL M3-1-ART3-A1
• Applicant: Bonart Co., Ltd.
• Product Code: ELC · Dental
• Decision Date: Mar 6, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4850
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

The ART Ultrasonic Scaler is a dental device used by clinicians for calculus removal. It consists of a main scaling unit, a handpiece, a footswitch, and interchangeable ultrasonic tips. The device operates at 25 kHz or 30 kHz frequencies, utilizing ultrasonic vibration to mechanically dislodge calculus deposits from tooth surfaces. It features adjustable power and water flow settings, along with a 'turbo' mode for enhanced performance. The handpiece is compatible with standard Cavitron-style inserts. The clinician controls the device via a footswitch, allowing for precise application during dental cleaning and periodontal therapy. By providing controlled ultrasonic energy, the device facilitates efficient removal of dental deposits, aiding in the maintenance of periodontal health.

Clinical Evidence

Bench testing only. Performance studies verified that the device conforms to applicable EN and IEC emission and immunity standards. No clinical data was required or provided to establish substantial equivalence.

Technological Characteristics

Ultrasonic scaling unit with handpiece, footswitch, and inserts. Operates at 25 kHz or 30 kHz. Features include adjustable power and water flow, and a turbo mode. Compatible with Cavitron-style inserts. Electrical safety and electromagnetic compatibility verified per EN and IEC standards.

Indications for Use

Indicated for dental cleaning and periodontal therapy to remove calculus deposits from teeth in patients requiring professional dental hygiene.

Regulatory Classification

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.

Predicate Devices

• Power Plus Scaler (K983029)
• 25/30 Multi-Function Ultrasonic Scaler (K964320)

Submission Summary (Full Text)

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## 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

| 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: | Dec. 4 .1999 |
| 14.2. DEVICE IDENTIFICATION | |
| a. Trade/Proprietary Name: | ART Ultrasonic Scaler |
| b. Classification Name: | Ultrasonic Scaler<br>21 CFR 872.4850 |

#### 14.3 IDENTIFICATION OF PREDICATE DEVICE

| Company | Device | 510(k) No. | Date Cleared |
|----------------------------------|-------------------------------------------|------------|--------------|
| TPC Advanced<br>Technology ,Inc. | Power Plus Scaler | K983029 | 01/29/99 |
| Tony Riso Co. | 25/30 Multi-Function<br>Ultrasonic Scaler | K964320 | 01/23/97 |

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## DEVICE DESCRIPTION 14.4

The BONART CO., LTD. ART Ultrasonic Scaler is available in two models: a 25 kHz power output and a 30 kHz power output. The Bonart ART comes equipped with a turbo mode and can be operated in scaling or perio mode functions. The Bonart ART Scaler 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 Cavitron and Bonart tips.

## 14.5 SUBSTANTIAL EQUIVALENCE

The Bonart ART Ultrasonic Scaler is substantially equivalent to the Power Plus Scaler in commercial distribution by TPC Advanced Technology Inc. and to the 25/30 Multi-Function Ultrasonic Scaler in commercial distribution by the Tony Riso Company.

The fundamental technical characteristics of the Bonart ART Scaler 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 and perio modes. There are 25 kHz and 30 kHz power output capabilities with the Bonart ART Scalers and the predicate devices. Power and water adjustment features are present in all units. The Bonart ART Ultrasonic Scaler and the predicate devices come equipped with handpieces and are compatible with Cavitron brand inserts.

## 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.

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ART Scaler Original Premarket 510(k) Notification

#### 14.7 TECHNOLOGICAL CHARACTERISTICS

A comparison of the technological characteristics of the Bonart ART Scaler with the predicate devices is provided within this submission. The Bonart ART Scaler and the predicate devices are composed of a scaling unit, handpiece, footswitch and inserts. The Bonart ART and predicate devices are compatible with Cavitron brand inserts. Both 25KHz and 30KHz power outputs are available with the Bonart ART and the predicate devices. Turbo functions, perio and scaling modes are also common to each of the units.

#### 14.8 PERFORMANCE DATA

The Bonart ART Scaler 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 Scaler conformed to all emission and immunity standards in accordance with EN and IEC regulations. Results of the testing showed that the Bonart ART Scaler performs as intended.

#### 510(K) CHECKLIST 14.9

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.

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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 186 Road Hsinchuang, Taipei Hsien Taiwan

Re : K994203 ART Ultrasonic Scaler ART-M3 Trade Name: Regulatory Class: II Product Code: ELC December 4, 1999 Dated: Received: December 13, 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 of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, qood 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 Requlations, Title 21, Parts 800 to 895. ਸ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (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 requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of

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Page 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 [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" (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 [phone] or [phone] or at its internet address "http://www.fdalgov/cdrh/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

Enclosure

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ART Scaler 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-M3 |
| Indication for Use: | The BONART CO., LTD. ART Ultrasonic Scaler is<br>intended for use during dental cleaning and periodontal<br>therapy to remove calculus deposits from teeth by<br>application of an ultrasonic vibrating scaler tip to the<br>teeth. |

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Runoer

(Division Sign-Off) Division of Dental, Infection Control,
and General Hoopital, Infection Control, and General Hospital Device 510(k) Number _

| Prescription Use | <div> <span> <svg fill="none" height="16" viewbox="0 0 16 16" width="16" xmlns="http://www.w3.org/2000/svg"> <path d="M5.44433 11.7297L15.4443 1.72973L14.0296 0.315033L5.44433 8.8999L1.97123 5.4268L0.556531 6.8415L5.44433 11.7297Z" fill="black"></path> </svg> </span> </div> |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| (Per 21 CFR 801.109) | |
| OR | |
| Over-The-Counter Use | |

CONFIDENTIAL