(149 days)
Source of illumination for curing dental is restorative materials.
BONART ART-L3 LED CURING LIGHT
This letter is a 510(k) clearance for a dental curing light, a device whose performance is assessed through physical characteristics rather than diagnostic accuracy. Therefore, the questions related to AI/algorithm performance (such as acceptance criteria, sample sizes for test/training sets, ground truth establishment, expert adjudication, MRMC studies, and standalone performance) are not applicable in this context.
Summary of the Device:
- Trade/Device Name: BONART ART-L3 LED CURING LIGHT
- Regulation Number: 872.6070
- Regulation Name: Ultraviolet Activator for Polymerization
- Regulatory Class: II
- Product Code: EBZ
- Indication for Use: Source of illumination for curing dental restorative materials.
The FDA has determined the device is substantially equivalent to legally marketed predicate devices, allowing it to proceed to market subject to general controls provisions of the Act.
{0}------------------------------------------------
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, symbolizing protection and care. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
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: K062289
Trade/Device Name: BONART ART-L3 LED CURING LIGHT Regulation Number: 872.6070 Regulation Name: Ultraviolet Activator for Polymerization Regulatory Class: II Product Code: EBZ Dated: December 21, 2006 Received: December 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, 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.
JAN - 9 2007
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.
{1}------------------------------------------------
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,
Susan Runne
for 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
{2}------------------------------------------------
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
Device Name:
BONART ART-L3 LED CURING LIGHT
Indication for Use:
Source of illumination for curing dental is restorative materials.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Sue Curry
ﺋﻴﺴﻴﺔ ﺍﻟﻤﺘﻮﺳﻂ ﺍﻟﻤﺘﻮﺳﻂ ﺍﻟﻤﺘﻮﺳﻂ ﺍﻟﻤﺘﻮﺳﻂ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ
(Division Sign-Om Division of in exinationalogy, General Hospital, 1791 - 11 Data Li Fatal Lievices
5144086664 K062289
Driginal 510(k) Submission Bonart Co., Ltd. FDA Reg. No.9710363 Device Name/Model: BONART ART-L3 LED CURING LIGHT
§ 872.6070 Ultraviolet activator for polymerization.
(a)
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.(b)
Classification. Class II.