EASY-CURE (CURING AND WHITENING LIGHT)

K992357 · Ics of North America, Inc. · EBZ · Aug 30, 1999 · Dental

Device Facts

• Record ID: K992357
• Device Name: EASY-CURE (CURING AND WHITENING LIGHT)
• Applicant: Ics of North America, Inc.
• Product Code: EBZ · Dental
• Decision Date: Aug 30, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.6070
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

Source of illumination for curing dental restorative materials, and for tooth whitening activities. This device is intended for use in: 1. Source of illumination for curing dental restorative materials, 2. Assisting in the whitening process in dental office.

Device Story

Easy-Cure™ Curing and Whitening Light is a high-intensity light source used in dental offices; operated by dental professionals. Device inputs electrical power (100-230 VAC); transforms energy into filtered light (400-500 nm) transmitted via optical fiber. Output is directed at dental restorative materials to facilitate curing or at teeth to assist whitening. Device provides clinical utility by enabling polymerization of resins and accelerating whitening treatments. No complex software or automated decision-making involved.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

High-intensity light source; 400-500 nm spectral output; optical fiber transmission; 100-230 VAC power input. Standalone dental equipment. No software or digital algorithm.

Indications for Use

Indicated for use in dental offices as a light source for curing dental restorative materials and as an aid in tooth whitening 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

• Plasma Arc Curing system (K952333)
• Ardent Radiance Curing Light (K982615)
• Spectrum 800 Curing Unit (K982318)
• CU-100A Light Cure Unit (K980792)
• O-Luxpro V/Q-Luxpro II Light Unit (K980793)

Submission Summary (Full Text)

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## XII, 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS (Separate Page)

A. Submitter: Alan A. Creamer, President, ICS of North American, Inc., 10054 Mesa Ridge Ct. San Diego, CA 92121

I. Classification: Class II and Class I.

II. Common or usual name: Curing and whitening light.

III. Proprietary Name: Easy-Cure™ Curing and Whitening Light

IV. Registration No .: 61073

V. Classification Name: Tooth-shade resin (Accessory) and, Heat source for bleaching teeth, Class II and Class I.

VI. Performance standards: None established under section 514.

VII. Description: The Easy-Cure™ Curing and Whitening Light is comprised of a high-intensity light source filtered and transmitted through an optical fiber for the curing of composite resins and as an aid in the whitening of teeth. The device emits filtered light in the range from 400 to 500 nm. It accepts voltages from 100-230 VAC.

VIII. Labels and Labeling: Labels and Instructions for Use are provided. Competitive labels and labeling are provided and the products are compared.

IX. Indications for Use: source of illumination for curing dental restorative materials, and for tooth whitening activities.

X. Substantial Equivalence: Easy-Cure™ Curing and Whitening Light is substantially equivalent to the Plasma Arc Curing system cleared by American Dental Technologies in K-952333, to the Ardent Radiance Curing Light cleared by Air Techniques, Inc., in K-982615, to the Spectrum 800 Curing Unit, cleared by Dentsply in K-982318, the CU-100A Light Cure Unit cleared in K-980792, the O-Luxpro V/Q-Luxpro II Light Unit cleared in K-980793 and several other curing lights cleared under code EBF as accessories to composite materials classified as "tooth-shade resin and described in CFR 872.3690.

The "510(k) Substantial Equivalence Decision-making Process (Detailed) from ODE Guidance Memorandum #86-3 was followed.

End of Summary

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We believe we have provided sufficient information to allow the determination of substantial equivalence for this device. We could not find any specific guidance documents on the subject but have complied with the terms of the general guidance documents for preparation of premarket notifications-510(k)s. If additional information or explanation is needed, please call me at 619-558-9203 or fax me at 619-558-1243. Alternately, you may contact Dr. H. N. Dunning at 301-229-2138, 8309 Bryant Dr., Bethesda, MD 20817, for a local response.

Sincerely yours

Alan A. Creamer
President

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the top half of the circle. Inside the circle is an abstract image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 30 1999

Mr. Alan A. Creamer President ICS of North America, Incorporated 10054 Mesa Ridge Court Suite 104-106 San Diego, California 92037

K992357 Re : EASY-CURE (CURING AND WHITENING LIGHT) Trade Name: Requlatory Class: II Product Code: EBZ Dated: July 14, 1999 Received: July 14, 1999

Dear Mr. Creamer:

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 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 aqainst 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 regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will

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### Page 2 - Mr. Creamer

verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to
premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski

Timb thy 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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IX. Indications for Use: {Separate Page}

510(k) Number: NA

Device Name: Easy-Cure™ Curing and Whitening Light.

This device is intended for use in:

- 1. Source of illumination for curing dental restorative materials,
- 2. Assisting in the whitening process in dental office.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Suxar Tuna
(Division Sign-Off)

Division of Dental, Infection Control, and General Hospital Devices k992335 510(k) Number

Prescription Use_ (Per 21 CFR 801.109)

or

Over-The-Counter Use_

(Optional Format 1-2-96)