I LIGHT

K072807 · Dent'N CO · EBZ · Nov 21, 2007 · Dental

Device Facts

• Record ID: K072807
• Device Name: I LIGHT
• Applicant: Dent'N CO
• Product Code: EBZ · Dental
• Decision Date: Nov 21, 2007
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 872.6070
• Device Class: Class 2
• Attributes: Therapeutic

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.

Device Story

I Light is a handheld, battery-operated LED dental curing light used by dental professionals in clinical settings. The device consists of a hand unit and a battery charger. It features a programmed control circuit and a high-intensity blue LED light source. Light is delivered to the oral cavity via a light guide and optical fiber. The device is used to photopolymerize camphorquinone-based VLC dental resins and bleaching materials. By applying high-intensity light to the treatment area, the device hardens dental materials, facilitating restorative procedures. The compact, contoured design allows for precise positioning within the oral cavity.

Clinical Evidence

Bench testing only. The device was tested for conformance with EN 60601/A2 (June 1995) and EN 60601-1-2 (November 2001). No clinical data provided.

Technological Characteristics

Handheld LED curing light; high-intensity blue LED source; programmed control circuit; light guide and optical fiber delivery; battery-powered with external charger; compact, contoured form factor. Conforms to EN 60601/A2 and EN 60601-1-2 standards.

Indications for Use

Indicated for polymerization of visible light cure (VLC) dental materials, including pit and fissure sealants, bonding adhesives, cements, and restorative or luting materials in patients requiring dental restorative procedures.

Regulatory Classification

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.

Predicate Devices

• SmartLite™ PS LED Curing Light, Dentsply (K041372)
• Elipar™ FreeLight, 3M ESPE AG (K011154)

Submission Summary (Full Text)

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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 [phone] fax

[e-mail]

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

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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.

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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.

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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 [phone]. 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 [phone] or [phone] 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 | <div> <span style="font-size: 2em;">✓</span> </div> | OR | Over-The-Counter Use (Per 21 CFR 801.109) |
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(Division Sign-Off)
Division of Anesthesiology, General Hospital
Infection Control, Dental Devices

| 510(k) Number: | K072807 |
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