BONART'S ARTEOTOMY OMI AND OPI ULTRASONIC SURGERY SYSTEM & ACCESSORIES

K080761 · Bonart Co., Ltd. · DZI · Aug 25, 2008 · Dental

Device Facts

• Record ID: K080761
• Device Name: BONART'S ARTEOTOMY OMI AND OPI ULTRASONIC SURGERY SYSTEM & ACCESSORIES
• Applicant: Bonart Co., Ltd.
• Product Code: DZI · Dental
• Decision Date: Aug 25, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4120
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The ARTeotomy Ultrasonic surgery system (OP1) uses piezoelectric ultrasonic technology to generate mechanical micro vibrations for bone cutting, with minimal soft tissue trauma. The system is supplied with sharp, smoothing and blunt insert tips for dental oral surgery use, including implantology, periodontal surgery and surgical orthodontics. Piezo tips come in various shapes and forms (BS-OTI, BS-OT3, BS-OT5 etc.) and are designed to generate a vibrating frequency of 26-32 kHz The ARTeotomy Ultrasonic Surgery System (OM1) uses magnetostrictive ultrasonic technology to generate mechanical micro vibrations for bone cutting, with minimal trauma to soft tissue. The system is supplied with sharp, smoothing and blunt insert for dental oral surgery use, including implantology, periodontal surgery and surgical orthodontics. Inserts come in various shapes and forms (ART-AS, ART-LH, ART-LV etc.) and are designed to generate a vibrating frequency of 24.5 kHz.

Device Story

Bonart-ARTeotomy Ultrasonic Surgery System (Models OP1 & OM1) performs bone cutting via mechanical micro-vibrations. OP1 utilizes piezoelectric technology (26-32 kHz); OM1 utilizes magnetostrictive technology (24.5 kHz). System includes various sharp, smoothing, and blunt insert tips for specific surgical tasks. Used in dental clinics by dental professionals for implantology, periodontal surgery, and surgical orthodontics. Device minimizes soft tissue trauma compared to traditional rotary instruments. Operation involves manual control by the clinician to guide the vibrating tip against bone tissue.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

System utilizes ultrasonic vibration for bone cutting. OP1: Piezoelectric technology (26-32 kHz). OM1: Magnetostrictive technology (24.5 kHz). Includes various interchangeable insert tips (sharp, smoothing, blunt).

Indications for Use

Indicated for dental oral surgery, including implantology, periodontal surgery, and surgical orthodontics, requiring bone cutting with minimal soft tissue trauma.

Regulatory Classification

Identification

A bone cutting instrument and accessories is a metal device intended for use in reconstructive oral surgery to drill or cut into the upper or lower jaw and may be used to prepare bone to insert a wire, pin, or screw. The device includes the manual bone drill and wire driver, powered bone drill, rotary bone cutting handpiece, and AC-powered bone saw.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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: K080761

Trade/Device Names: Bonart-ARTeotomy Ultrasonic Surgery System (Model No. OP1 & OM1) Regulation Number: 21 CFR 872.4120 Regulation Name: Bone Cutting Instrument and Accessories Regulatory Class: II Product Code: DZI Dated: August 19, 2008 Received: August 20, 2008

AUG 2 5 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 [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Chiu 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

K080761

510(k) Number (if known): To be assigned by FDA

Device Name: Bonart- ARTeotomy Ultrasonic Surgery System (Model No. OP1 & OM1)

Indications For Use:

The ARTeotomy Ultrasonic surgery system (OP1) uses piezoelectric ultrasonic technology to generate mechanical micro vibrations for bone cutting, with minimal soft tissue trauma. The system is supplied with sharp, smoothing and blunt insert tips for dental oral surgery use, including implantology, periodontal surgery and surgical orthodontics. Piezo tips come in various shapes and forms (BS-OTI, BS-OT3, BS-OT5 etc.) and are designed to generate a vibrating frequency of 26-32 kHz

The ARTeotomy Ultrasonic Surgery System (OM1) uses magnetostrictive ultrasonic technology to generate mechanical micro vibrations for bone cutting, with minimal trauma to soft tissue. The system is supplied with sharp, smoothing and blunt insert for dental oral surgery use, including implantology, periodontal surgery and surgical orthodontics. Inserts come in various shapes and forms (ART-AS, ART-LH, ART-LV etc.) and are designed to generate a vibrating frequency of 24.5 kHz.

Prescription Use ﺍﻟﻜﻠ (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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Ruane

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

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510(k) Number: K080676