COLTOLUX LED CURING LIGHT

K040551 · Coltene/Whaledent, Inc. · EBZ · Mar 15, 2004 · Dental

Device Facts

• Record ID: K040551
• Device Name: COLTOLUX LED CURING LIGHT
• Applicant: Coltene/Whaledent, Inc.
• Product Code: EBZ · Dental
• Decision Date: Mar 15, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.6070
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

This device is indicated for the polymerization of intra oral and extra oral restorations fabricated from materials [commonly referred to as visible light cured dental restoratives and/or composites and/or dental adhesives ] that contain Camphorquinone as the photo initiator.

Device Story

Coltolux LED Curing Light is a dental device used for polymerization of light-cured restorative materials. Device utilizes LED technology to emit light at specific wavelengths to activate Camphorquinone photo-initiators in dental composites and adhesives. Operated by dental professionals in clinical settings; device provides controlled light output to harden restorative materials during dental procedures. Benefits include efficient curing of dental restorations, ensuring structural integrity and proper setting of materials.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

LED-based light curing system; emits light at wavelengths specific to Camphorquinone activation; handheld form factor; electrical power source.

Indications for Use

Indicated for polymerization of intra-oral and extra-oral dental restorations, composites, and adhesives containing Camphorquinone photo-initiator.

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

MAR 1 5 2004

Coltene/Whaledent Incorporated C/O Mr. Henry J. Vogelstein Consultant 1349 Lexington Avenue New York, New York 10128

Re: K040551

Trade/Device Name: Coltolux® LED Curing Light Regulation Number: 21 CFR 872.6070 Regulation Name: Ultraviolet Activator for Polymerization Regulatory Class: II Product Codes: EBZ Dated: February 29, 2004 Received: March 02, 2004

Dear Mr. Vogelstein:

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 - Mr. Henry J. Vogelstein

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 (QS) 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]. 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) you may obtain. Other general information on your responsibilities under the Act may be obtained 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/clsma/dsmamain.html

Sincerely vours.

Keir Muly

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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Coltène/Whaledent Inc. 510(k) Submission

| | Indications for Use | |
|---------------------------|---------------------|---------|
| 510(k) Number (if known): | Not known | K040551 |

Device Name: Coltolux LED Curing Light

Indications for Use:

This device is indicated for the polymerization of intra oral and extra oral restorations fabricated from materials [commonly referred to as visible light cured dental restoratives and/or composites and/or dental adhesives ] that contain Camphorquinone as the photo initiator.

Prescription Use
(21 CFR Part 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR Part 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Russo

Clivision Sign-Off)
Division of Anesthesiology, General Hospital,
Division of Anesthesental Devices
Confrol, Dontrol, Devices (Devices ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------(Division Sign of Anesiology, Golf
Division of Anesthesiology, Dental Devicess
Infection Control, Dentrol, Devices

510(k) Number.