(34 days)
Source of illumination for curing dental restorative materials.
The Nova-Pulse cordless battery operated hand-held light is a cordless curing light using light emitting diodes. No filters are required to bloc out harmful and unnecessary rays. The light produced by these diodes is specifically in the optimum curing range of 10 to 500 nanometers
This document is a 510(k) summary for the Nova-Pulse Cordless Curing Light, which is a dental device used for curing restorative materials. This type of device, which is an ultraviolet activator for polymerization, typically undergoes performance testing related to its output wavelength, intensity, and ability to effectively cure dental materials. However, the provided text does not contain any information about acceptance criteria, device performance results, or any studies conducted to prove the device meets specific criteria.
The document primarily covers:
- General administrative information about the 510(k) submission.
- A brief description of the device (cordless, LED-based, optimal curing range of 10 to 500 nanometers).
- Its intended use (source of illumination for curing dental restorative materials).
- The FDA's letter of clearance, stating that the device is substantially equivalent to a legally marketed predicate device (K000393 – Nova Cordless™ Curing Light).
Therefore, I cannot provide the requested information. The document focuses on regulatory clearance based on substantial equivalence, rather than detailed performance study results.
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JAN - 3 2005
Cooco3
510(k) Summary
| Date prepared: | September 22, 2004 |
|---|---|
| Submitter/Owner: | Nova Ranger, Inc.9885 Mesa Rim Rd.Suite 127San Diego, CA 92121 |
| Contact person: | Curtis M. Egan16787 Bernardo Center Drive, Suite A-1San Diego, CA 92128 |
| Phone number: | (858) 675-8200 |
| Fax number: | (858) 675-8201 |
| Proprietary name: | Nova-Pulse |
| Common name: | Nova-Pulse |
| Classification: | Class II. 872.6070 Ultraviolet activator for polymerization |
| Product Code: | EBZ |
Substantial equivalence claimed to:
.
- K000393 – Nova Cordless™ Curing Light
Special 510(k) Submission for Nova Ranger, Inc.
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Description:
The Nova-Pulse cordless battery operated hand-held light is a cordless curing light using light emitting diodes. No filters are required to bloc out harmful and unnecessary rays. The light produced by these diodes is specifically in the optimum curing range of 10 to 500 nanometers
Intended use: Source of illumination for curing dental restorative materials
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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 consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN - 3 2005
Nova Ranger, Incorporated C/O Mr. Curtis M Egan Regulatory Specialist Certified Software Solutions, Incorporated 16787 Bernardo Center Drive, Suite A-1 San Diego, California 92128
Re: K043302
Trade/Device Name: Nova-Pulse Cordless Curing Light Regulation Number: 872.6070 Regulation Name: Ultraviolet Activator for Polymerization Regulatory Class: II Product Code: EBZ Dated: December 20, 2004 Received: December 23, 2004
Dear Mr. Egan:
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. Egan
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 (240) 276-0115. 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 from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours.
Senite Y. M.Chine MD. FOR
DR. CHIU LIN
Chiu Lin, Ph.D. 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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(Attachment I)
Indications for Use
510(k) Number (if known): N/A
Device Name: Nova-Pulse Cordless Curing Light
Indications For Use: Source of illumination for curing dental restorative materials.
Prescription Use X AND/OR
Over-The-Counter Use
(Part 21 CFR 801 Subpart D)
(21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mellidafle for MSR
Page 1 of 1 on Sign-Off)
on of Anesthesiology, General Hospital, Infection Control, Dental De
510(k) Number: _
§ 872.6070 Ultraviolet activator for polymerization.
(a)
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.(b)
Classification. Class II.