AURORA

K063003 · Parkell, Inc. · EBZ · Nov 28, 2006 · Dental

Device Facts

• Record ID: K063003
• Device Name: AURORA
• Applicant: Parkell, Inc.
• Product Code: EBZ · Dental
• Decision Date: Nov 28, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.6070
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

For the polymerization of visible light cured dental materials.

Device Story

Aurora LED Curing Light is a dental device used for the polymerization of light-cured dental materials. It utilizes LED technology to emit visible light, which initiates the curing process of restorative materials. The device is intended for use by dental professionals in a clinical environment. By providing a controlled light source, it enables the hardening of dental composites and adhesives, facilitating restorative dental procedures. The device is operated by the clinician to ensure proper material setting, which is essential for the structural integrity and longevity of dental restorations.

Clinical Evidence

Bench testing only.

Technological Characteristics

LED-based light curing device; classified as an ultraviolet activator for polymerization (21 CFR 872.6070); product code EBZ; Class II device.

Indications for Use

Indicated for the polymerization of visible light cured dental materials in a clinical 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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NOV 2 8 2006

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Daniel R. Schechter, Esq. General Counsel Parkell Incorporated 300 Executive Drive, Box 9004 Edgewood, New York 11717

Re: K063003 Trade/Device Name: Aurora™ Regulation Number: 21 CFR 872.6070 Regulation Name: Ultraviolet Activator for Polymerization Regulatory Class: II Product Code: EBZ Dated: September 29, 2006 Received: October 03, 2006

Dear Mr. Schechter:

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 - Daniel R. Schechter, Esq.

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 (OS) 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 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,

Susan Kump

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

510(k) Number (if known): Unknown

Device Name: AURORA LED Curing Light

Indications for Use:

For the polymerization of visible light cured dental materials.

Prescription Use XX (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Susan Burns

കാര്‍ത്തും എ - 9:44 | by | onlini, C. Mai . evioses

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