(66 days)
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No
The summary describes a light curing unit for dental fillings, focusing on optical properties and light power density. There is no mention of AI, ML, image processing, or data-driven algorithms.
Yes
The device is described as a "light curing unit" used in "dentistry" to "achieve tooth filling effect" by interacting with "mixed resin of dentistry filling substances." This indicates it's used for medical treatment, specifically dental restoration.
No
The device, ART-L2 LIGHT CURING UNIT, is described as using light to cure dental filling materials, which is a therapeutic or treatment-oriented function, not a diagnostic one.
No
The device description and intended use clearly describe a hardware device (light curing unit) that uses optical components and fiber optics to cure dental filling material. There is no mention of software being the primary or sole component.
Based on the provided information, the ART-L2 LIGHT CURING UNIT is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the device's function as using light to cure dental filling materials in the tooth. This is a direct treatment or procedure performed on the patient's body.
- IVD Definition: IVDs are devices used to examine specimens (like blood, urine, tissue) taken from the human body to provide information about a person's health. The ART-L2 does not involve the analysis of such specimens.
- Anatomical Site: The anatomical site is the "tooth," which is part of the patient's body, not a specimen taken from the body.
Therefore, the ART-L2 is a therapeutic or procedural device used in dentistry, not an in vitro diagnostic device.
N/A
Intended Use / Indications for 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.
Product codes
EBZ
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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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.
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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three human profiles incorporated into its design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
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 (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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 |
| 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. |
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
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