(38 days)
ART-L5 LED Cordless Curing Light System is used in light polymerization of dental composite and curing dental restorative thru source of illuminations.
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This document is a 510(k) clearance letter from the FDA for a dental curing light, the BONART ART-L5 LED Cordless Curing Light. It primarily addresses regulatory approval based on "substantial equivalence" to a predicate device, rather than providing details of a study with specific acceptance criteria and performance metrics for a novel AI or medical imaging device.
Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, adjudication, MRMC studies, standalone performance, and ground truth establishment is not available in the provided text.
The document confirms that:
- Device Name: BONART ART-L5 LED Cordless Curing Light System
- Indications For Use: Used in light polymerization of dental composite and curing dental restorative through a source of illuminations.
- Regulatory Class: II
- Product Code: EBZ (Ultraviolet Activator for Polymerization)
The FDA's review determined the device is substantially equivalent to legally marketed predicate devices. This means that Bonart Company, Limited did not need to conduct a new clinical trial or extensive performance study demonstrating compliance with a specific set of acceptance criteria in the same way a novel high-risk device might. Instead, they demonstrated that their device performs as safely and effectively as an already-approved device.
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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: K082971
Trade/Device Name: BONART ART-L5 LED CORDLESS CURING LIGITT Regulation Number: 872.6070 Regulation Name: Ultraviolet Activator for Polymerization Regulatory Class: II Product Code: EBZ Dated: October 2, 2008 Received: October 6, 2008
NOV 1 3 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 cnclosure) 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.
lf your device is classified (sec above) into cither 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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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 (240) 276-0115. 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 (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Snegite Y. Michael Daro.
Chiu S. Lin, Ph. D Division 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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Indications for Use
510(k) Number (if known): To be assigned by FDA
Device Name: Bonart- ART-L5 LED Cordless Curing Light System
Indications For Use:
ART-L5 LED Cordless Curing Light System is used in light polymerization of dental composite and curing dental restorative thru source of illuminations.
Prescription Use 2 (Part21 CFR 801 SubpartD)
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 Runner
ision of Anesthesiology, General Hospital, ction Control, Dental Devices
510(k) Number. K88297
Page 1 of
Original 510(k) Submission Bonart Co., Ltd. FDA Reg. No.9710363 Device Name/Model: BONART ART-L5 LED CORDLESS CURING LIGHT
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§ 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.