(51 days)
Not Found
No
The description focuses on the hardware components and basic programmed control circuit, with no mention of AI, ML, image processing, or data-driven learning.
No.
The device polymerizes dental materials, which is a functional process rather than a direct therapeutic treatment of a disease or condition in the patient.
No
The device is described as an intraoral curing light designed to polymerize dental materials, which is a treatment function, not a diagnostic one.
No
The device description clearly states it is a LED curing light with a hand unit containing hardware components like a programmed control circuit, LED light source, light guide, and optical fiber, and also includes a battery charger. This indicates it is a physical device with embedded software, not a software-only medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is designed to "polymerize visible light cure (VLC) dental materials" in the oral cavity. This is a direct treatment or procedure performed on a patient, not a test performed on a sample taken from the body.
- Device Description: The description details a device that delivers light to a treatment area on the patient. This aligns with a therapeutic or procedural device, not a diagnostic one.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information about a patient's health status.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is to cure dental materials in situ within the patient's mouth.
N/A
Intended Use / Indications for Use
The I Light intraoral curing light is designed to polymerize visible light cure (VLC) dental materials, including dental pit and fissure sealants, bonding adhesives, cements, restorative or luting materials.
Product codes
EBZ
Device Description
The I Light is a LED curing light that is small, easy to use, and swift in curing. It has a compact, lightweight hand piece, with a curved and contoured tip, to allow the light to be positioned and applied anywhere in the oral cavity. It consists of a hand unit and a battery charger. The hand unit contains a programmed control circuit, high intensity dental blue LED light source, a light guide and an optical fiber that conducts light to the treatment area on the patient.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
oral cavity
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The I Light was tested, and determined to be in conformance with, EN 60601/A2 of June 1995 and EN 60601-1-2 of November 2001.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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
K67280
NOV 2 1 2007
510(k) Summary
In accordance with the Safe Medical Devices Act (SMDA) of 1990 and Title of the Code of Federal Regulations Part 807 (21 CFR §807), and in particular §807.92, the following summary of safety and effectiveness information is provided:
Submitted by
Alan Donald, MS, MBA, RAC President Matrix Medical Consulting, Inc. 11440 West Bernardo Court, Suite 200 San Diego, California 92127
858-485-8584 phone 858-573-1801 fax
Date Prepared: September 18, 2007.
Device Name
Trade or Proprietary Name:
I LIGHT
Common or Usual Name:
Classification Name:
Ultraviolet Activator for Polymerization
21 CFR §872.6070
Dental Curing Light
Predicate Devices
SmartLite™ PS LED Curing Light, Dentsply, K041372 Elipar™ FreeLight, 3M ESPE AG, K011154
Device Description
The I Light is a LED curing light that is small, easy to use, and swift in curing. It has a compact, lightweight hand piece, with a curved and contoured tip, to allow the
1
light to be positioned and applied anywhere in the oral cavity. It consists of a hand unit and a battery charger. The hand unit contains a programmed control circuit, high intensity dental blue LED light source, a light guide and an optical fiber that conducts light to the treatment area on the patient.
Intended Use
The I Light intraoral curing light is designed to polymerize visible light cure (VLC) dental materials including dental pit and fissure sealants, bonding adhesives, cements, restorative or luting materials.
This indication applies also to the SmartLite™ and Elipar™ FreeLight predicate devices.
Comparison to Predicate Devices
The I Light and its predicate devices are similar electromedical devices in that have nearly identical indications for use and have similar technological features and capabilities. The I Light and its predicate devices all utilize the same technology -- LED activation to cause photopolymerization of camphorquinone-based visible light cured (VLC) dental resins and bleaching materials. The devices are substantially equivalent in intended use, operation, wavelength range, and light source.
Non-Clinical Tests
The I Light was tested, and determined to be in conformance with, EN 60601/A2 of June 1995 and EN 60601-1-2 of November 2001.
Conclusions
The predicate devices, as well as other similar ones, have been used in the marketplace for many years. Their safety and effectiveness are well established.
The above summary shows that there is adequate information and data to enable the FDA to determine the I Light is substantially equivalent to the Epilar™ FreeLight and the SmartLite™ PS.
2
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Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three stripes forming its body and wing. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" is arranged in a circular pattern around the eagle.
NOV 2 1 2007
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DENT'N CO C/O Mr. Alan Donald President Matrix Medical Consulting, Incorporated 11440 West Bernardo Court, Suite 200 San Diego, California 92127
Re: K072807
Trade/Device Name: I LIGHT Dental Curing Light Regulation Number: 21 CFR 872.6070 Regulation Name: Ultraviolet Activator for Polymerization Regulatory Class: II Product Code: EBZ Dated: September 25, 2007 Received: October 1, 2007
Dear Mr. Donald:
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.
3
Page 2- Mr. Donald
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.
Swan Luna
on 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
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Indications for Use
510(k) Number (if known):
Device Name: I LIGHT Dental Curing Light
Indications for Use:
The I Light intraoral curing light is designed to polymerize visible light cure (VLC) dental materials, including dental pit and fissure sealants, bonding adhesives, cements, restorative or luting materials.
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use | ✓ | OR | Over-The-Counter Use (Per 21 CFR 801.109) |
|---|---|---|---|
| ------------------ | ----------------------------------------------------- | ---- | ------------------------------------------- |
(Division Sign-Off)
Division of Anesthesiology, General Hospital
Infection Control, Dental Devices
| 510(k) Number: | K072807 |
|---|---|
| ---------------- | --------- |