JETLITE 5000

K051780 · J. Morita USA, Inc. · EBZ · Jul 28, 2005 · Dental

Device Facts

• Record ID: K051780
• Device Name: JETLITE 5000
• Applicant: J. Morita USA, Inc.
• Product Code: EBZ · Dental
• Decision Date: Jul 28, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.6070
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Jetlite 5000 is intended to polymerize (set) resinous dental pit and fissure sealants or dental restorative materials by transmission of light through a rod.

Device Story

Jetlite 5000 is a dental curing light used by dental professionals to polymerize resinous dental materials. Device utilizes a light rod to transmit light to the target material. Operation involves manual activation by the clinician to initiate light emission, which cures the resinous sealant or restorative material. Used in dental clinical settings to facilitate dental procedures requiring light-cured materials.

Clinical Evidence

Bench testing only.

Technological Characteristics

Ultraviolet activator for polymerization; light transmission via rod; Class II device; Product Code EBZ.

Indications for Use

Indicated for polymerization of resinous dental pit and fissure sealants or dental restorative materials in dental patients.

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.

Submission Summary (Full Text)

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 288 2005

Mr. Howard Rowe Consultant J. Morita USA, Incorporated 9 Mason Irvine, California 92618

Re: K051780

Trade/Device Name: Jetlite 5000 Regulation Number: 21 CFR 872.6070 Regulation Name: Ultraviolet Activator for Polymerization Regulatory Class: II Product Code: EBZ Dated: June 23, 2005 Received: July 01, 2005

Dear Mr. Rowe:

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. Howard Rowe

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" (21 CFR 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.

Syettie Y. Michie Oms

Chiu S. Lin, PhD 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 Statement

| 510(k) Number (if known): | <del>Not Assigned to date</del> k051780 |
|---------------------------|-----------------------------------------|
|---------------------------|-----------------------------------------|

Device Name:

Jetlite 5000

Indications For Use:

The Jetlite 5000 is intended to polymerize (set) resinous dental pit and fissure sealants or dental restorative materials by transmission of light through a rod. .

(PLEASE DO NOT WRITE BELIOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

| (Division Sign-Off) | |
|---------------------------------------------------------------------------------|---------|
| Division of Anesthesiology, General Hospital, Infection Control, Dental Devices | |
| 510(k) Number: | K051780 |

| Prescription Use<br>(Per 21 CFR 801.109) | <div style="text-align: left;">✓</div> | OR | Over-The-Counter Use |
|------------------------------------------|----------------------------------------|----|----------------------|
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