GC E-LIGHT

K012134 · GC America, Inc. · EBZ · Aug 7, 2001 · Dental

Device Facts

• Record ID: K012134
• Device Name: GC E-LIGHT
• Applicant: GC America, Inc.
• Product Code: EBZ · Dental
• Decision Date: Aug 7, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.6070
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Source of illumination for curing visible light cured dental materials such as composites and resin cements.

Device Story

GC E-Light is a dental curing light used by dental professionals to polymerize light-activated restorative materials. The device provides a source of illumination to initiate the curing process of composites and resin cements. It is intended for use in a clinical environment to facilitate dental procedures requiring light-cured materials. The device output allows the clinician to harden dental resins, directly affecting the setting time and structural integrity of dental restorations.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Dental curing light; visible light source for polymerization of dental materials; standalone device; intended for clinical use.

Indications for Use

Indicated for use as a light source to cure visible light-activated dental materials, including composites and resin cements, in a clinical 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)

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AUG - 7 2001

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Terry L. Joritz Director of Requlatory Affairs & Quality Control GC America, Incorporated 3737 West 127th Street Alsip, Illinois 60803

Re : K012134 Trade/Device Name: GC E-Light Requlation Number: 872.6070 Regulatory Class: II Product Code: EBZ Dated: July 6, 2001 Received: July 9, 2001

Dear Mr. Joritz:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ਸ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in requlatory In addition, FDA may publish further announcements action.

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Page 2- Mr. Joritz

concerning your device in the Federal Register. Please note: concerning your device in and ification submission does this response to your premaint have under sections 531 not arrect any obligation for devices under the Electronic Chrough 542 Of the Act 101 xevisions, or other Federal laws or requlations.

This letter will allow you to begin marketing your device as mis lecter wour 510 (k) premarket notification. The FDA described in your sio\n privalence of your device to a legally I inding of substancial equivaler of classification for your marketed predicate device robated to proceed to the market.

If you desire specific advice for your device on our labeling II you desire bpcorrer additionally 809.10 for in regulacion (21 crk raros), please contact the Office of Compliance at [phone]. Additionally, for questions on Compriance at (501) 3941, Jertising of your device, please contact the Office of Compliance at [phone]. Also, please note the requlation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general premation on your responsibilities under the Act may be obtained from the Division of Small Manufacturers obtained from the Bivibion on its toll-free number Incernational and combined - 6597 or at its internet address (000) : //www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski

Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## KO12134

510(k) Number (if known): Ko 12 12 12 12 4

Device Name: GC e-Light_______________________________________________________________________________________________________________________________________________________

## Indications For Use:

Source of illumination for curing visible light cured dental materials such Source of firmination for caring views in one cements.

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

## Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

OR

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

(Optional Formal 1-2-96)

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devig 510(k) Number .