BLUELEX

K051203 · Monitex Industrial Co., Ltd. · EBZ · May 25, 2005 · Dental

Device Facts

• Record ID: K051203
• Device Name: BLUELEX
• Applicant: Monitex Industrial Co., Ltd.
• Product Code: EBZ · Dental
• Decision Date: May 25, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.6070
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

The intended use of the BlueLEX LD-105 is for the polymerization of light cure materials.

Device Story

BlueLEX LD-105 is a dental curing light used for the polymerization of light-activated restorative materials. Device emits high-intensity light to initiate chemical hardening of dental resins. Operated by dental professionals in clinical settings. Provides controlled light output to ensure proper material curing, facilitating dental restorations and procedures.

Clinical Evidence

Bench testing only.

Technological Characteristics

Ultraviolet activator for polymerization; Class II device; Product Code EBZ; Regulation 872.6070.

Indications for Use

Indicated for the polymerization of light cure materials in a clinical or dental setting.

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)

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features the department's name in a circular arrangement around a symbol. The symbol consists of a stylized caduceus, which is a staff with two snakes entwined around it, representing medicine and health.

Public Health Service

MAY 2 5 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Monitex Industrial Company Limited C/O Mr. Marc M. Mouser Responsible Third Party Official Underwriters Laboratories, Incorporated 2600 N.W. Lake Road Camas, Washington 98607-8542

Re: K051203

Trade/Device Name: BlueLEX LD-105 Regulation Number: 872.6070 Regulation Name: Ultraviolet Activator for Polymerization Regulatory Class: II Product Code: EBZ Dated: May 3, 2005 Received: May 11, 2005

Dear Mr. Mouser:

We have reviewed your Section 510(k) premarket notification of intent to market the device we have to reveal your 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 merslate conments, or to devices that have been reclassified in accordance with the provisions of Ameliuments, or to de research Act (Act) that do not require approval of a premarket the rederal I vou, Drag, and Commay, therefore, market the device, subject to the general approvin upprication (1) ... The general controls provisions of the Act include controls provisions of the eightration, 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 IT your device is classified (500 as additional controls. Existing major regulations affecting (1 MA), it may of subject to back and regulations, Title 21, Parts 800 to 898. In your device can or round in the bear in the bear ing your device in the Federal Register.

{1}------------------------------------------------

## Page 2 - Mr. Mouser

Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advisou that 1 DT 3 lesalites on that your device complies with other requirements mean that I DA mas made a wees and regulations administered by other Federal agencies. of the Act of ally I ederal statutes and equirements, including, but not limited to: registration 1 ou must comply with an the Hevelong (21 CFR Part 801); good manufacturing practice allu listing (21 CF K Furt 607), labelity systems (QS) regulation (21 CFR Part 820); and if requirements as set form in the quality of oversions (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) This letter will anow you to objal finding of substantial equivalence of your device to a premits in the around - The PDF 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), If you desire specific at no for your ce 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 may obtain of Small Manufacturers, International and Consumer Assistance at its toll-free Dribber [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

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

{2}------------------------------------------------

## Indication for Use

510(K) Number (if known):

Device Name: BlueLEX LD-105

Indication For Use:

The intended use of the BlueLEX LD-105 is for the polymerization of light cure materials.

Prescription Use \u2713 AND / OR Over-The-Counter Use *_*_

(Part 21 CFR 801 Subpart D)

(21 CFR 801 Subpart C)

1 ୧

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Supa Runoo

(Division Sign-Off) Division of Anesthes Infection Control, D.

510(k) Number: