COOLBLU2 DENTAL RESIN CURING DEVICE

K020171 · Dental Systems.Com, Inc. · EBZ · Jan 29, 2002 · Dental

Device Facts

• Record ID: K020171
• Device Name: COOLBLU2 DENTAL RESIN CURING DEVICE
• Applicant: Dental Systems.Com, Inc.
• Product Code: EBZ · Dental
• Decision Date: Jan 29, 2002
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 872.6070
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The CoolBlu2 curing light is intended as a source of illumination for the curing of dental restorative materials.

Device Story

CoolBlu2 is a dental resin curing device used by dental professionals in clinical settings. It functions as an illumination source to initiate the polymerization of light-cured dental restorative materials. The device provides the necessary light energy to harden resins used in dental restorations. It is operated by dentists or dental staff to facilitate restorative procedures, directly affecting the setting time and structural integrity of dental materials used in patient treatment.

Clinical Evidence

Bench testing only.

Technological Characteristics

Ultraviolet activator for polymerization; dental resin curing light; Class II device; Product Code EBZ.

Indications for Use

Indicated for use by dental professionals as a light source to polymerize/cure dental restorative materials.

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

JAN 2 9 2002

Mr. Shinobu Doi Vice President Dental Systems, Incorporated 1187 Tadsworth Terrace Heathrow, Florida 32746

Re: K020171

Trade/Device Name: CoolBlu2 Regulation Number: 872.6070 Regulation Name: Ultraviolet Activator for Polymerization Regulatory Class: II Product Code: EBZ Dated: January 11, 2002 Received: January 17, 2002

Dear Mr. Doi:

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.

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.

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Page 2 - Mr. Doi

You must comply with all the Act's requirements, including, but not limited to: registration r od intiles comply was 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 roquicable, 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 I his lotter will and it your your 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 and additionally 21 CFR Part 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and the receined at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

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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510(k) Number (if known):

KOLO\71

Device Name: CoolBlu2 Dental Resin Curing Device

Indication for Use:

## CoolBlu2 Dental Resin Curing Device

Intended Use The CoolBlu2 curing light is intended as a source of illumination for the curing of dental restorative materials.

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Prescription Use _

OR

Over-the-Counter Use (Optional Format 1-2-96)

(Per 21 CFR 801.109)

Swser Ruse

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Division of Dental, Infection Control. ്നർ General Hospital Devices 510(k) Number -