BONART ART-L2 LIGHT CURING UNIT

K023721 · Bonart Co., Ltd. · EBZ · Jan 10, 2003 · Dental

Device Facts

• Record ID: K023721
• Device Name: BONART ART-L2 LIGHT CURING UNIT
• Applicant: Bonart Co., Ltd.
• Product Code: EBZ · Dental
• Decision Date: Jan 10, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.6070
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

ART-L2 uses the optical characteristics of the light to generate radial spectrum of the bulb to go through the optical lens and produce appropriate radial light power density via optical fiber and projected on the mixed resin of dentistry filling substances special filling material to achieve tooth filling effect.

Device Story

ART-L2 Light Curing Unit is a dental device used by clinicians to harden light-activated resin filling materials. The device utilizes an internal bulb to generate a radial light spectrum, which is directed through an optical lens and transmitted via an optical fiber tip. The clinician projects this light onto the dental resin placed in the patient's tooth, initiating polymerization to achieve a cured filling. The device is intended for use in a clinical dental setting.

Clinical Evidence

Bench testing only.

Technological Characteristics

The device consists of a light source (bulb), optical lens, and optical fiber for light delivery. It operates as an ultraviolet activator for polymerization (21 CFR 872.6070).

Indications for Use

Indicated for use in dentistry to polymerize light-cured dental filling materials (resins) for tooth restoration.

Regulatory Classification

Identification

An ultraviolet activator for polymerization is a device that produces ultraviolet radiation intended to polymerize (set) resinous dental pit and fissure sealants or restorative materials by transmission of light through a rod.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Bonart Company LTD C/O Mr. Eric L. Ong Manager Bonart Medical Technology, Incorporate 398 S. Lemon Creek Drive, Suite L Walnut, California 91789

JAN 1 0 2003

Re: K023721

Trade/Device Name: ART-L2 Light Curing Unit Regulation Number: 21 CFR 872.6070 Regulation Name: Ultraviolet Activator for Polymerization Regulatory Class: II Product Code: EBZ Dated: October 31, 2002 Received: November 05, 2002

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 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. Eric L. 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 (OS) 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 [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" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html

Sincerely yours,

Timothy A. Ulatowski

Timothy . Ulatowski Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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## INDICATION FOR USE

Applicant: Bonart Co., Ltd. Rm.405, No.3 Wuchuan 1st Road Hsinchuang, Taipei Hsien, Taiwan, R.O.C. FDA Registration Number: 9710363

| 510(k) Number: | To be assigned by FDA K023721 |
|---------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | ART-L2 LIGHT CURING UNIT |
| Indication for Use: | ART-L2 uses the optical characteristics of the light to<br>generate radial spectrum of the bulb to go through the<br>optical lens and produce appropriate radial light power<br>density via optical fiber and projected on the mixed resin<br>of dentistry filling substances special filling material<br>to achieve tooth filling effect. |

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Runner

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

510(k) Number: K023721

Original 510 (k) Submission Bonart Co., Ltd. FDA Reg. No. 9710363 Device Name/Model: ART-L2 Light Curing Unit