(28 days)
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Not Found
No
The summary describes a light activation system for dental resins and explicitly states that AI, DNN, or ML are "Not Found".
No
Explanation: The device is described as a "Light Activation System for Dental Restorative Resins," which indicates it's used for curing dental materials, not for therapeutic treatment of a disease or condition.
No
Explanation: The device is described as a "Light Activation System for Dental Restorative Resins," which indicates its function is to cure or harden dental materials, not to diagnose conditions or diseases.
No
The device description "SunliteLED Model #2810" and the intended use "Light Activation System for Dental Restorative Resins" strongly suggest a hardware device (an LED light system) used for curing dental materials, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "Light Activation System for Dental Restorative Resins." This describes a device used to cure dental materials within the patient's mouth, which is a direct treatment application.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections. The device described does not perform any such testing on biological samples.
The device's function is to activate a material used in dental restoration, which is a therapeutic procedure, not a diagnostic one.
N/A
Intended Use / Indications for Use
Light Activation System for Dental Restorative Resins
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an emblem of an eagle with three stylized feathers.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT - 2 2001
Mr. William J. Becker President Kinetic Instruments, Incorporation 17 Berkshire Boulevard Bethel, Connecticut 06801
Re: K012946
Trade/Device Name: SuniteLed Model #2810 Regulation Number: 872.6070 Regulation Name: Dental Regulatory Class: II Product Code: EBZ Dated: September 1, 2001 Received: September 4, 2001
Dear Mr. Becker:
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.
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.
1
Page 2 - Mr. Becker
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), 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). 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,
Timoth A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
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KOI 2946
INDICATIONS FOR USE STATEMENT
Ver/ 3 - 4/24/96
Applicant: Kinetic Instruments Inc.
510(k) Number (if known): N/A
Device Name: SunliteLED
Indications For Use:
Light Activation System for Dental Restorative Resins
Susan Runno
(Division Sign-Off) (Division Sign-On)
Division of Dental, Infection Control, and General Hospita 510(k) Number
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Per 21 CFR 801.109)
(Optional Format 1-2-96)