(89 days)
The dialal curing light and accessories, Cool Cure, is used to provide a source of illumination for curing dental restorative matcrials in the mouth.
Cool Cure, Dental Curing Light and Accessories
I am sorry, but based on the text provided, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them. The document is a 510(k) clearance letter from the FDA for a dental curing light, and it does not contain the detailed information about acceptance criteria, study design, sample sizes, ground truth establishment, or expert qualifications that you are asking for.
The document primarily focuses on establishing "substantial equivalence" to a predicate device, which is a regulatory pathway, not a detailed scientific study report demonstrating performance against specific acceptance criteria.
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Public Health Service
JUN 1 0 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Samm. Incorporated C/O Mr. W. Edward Johansen 11661 San Vincente Boulevard Los Angeles, California 90049
Re: K030811
Trade/Device Name: Cool Cure, Dental Curing Light and Accessories Regulation Number: 872.6070 Regulation Name: Ultraviolet Activator for Polymerization Regulatory Class: II Product Code: EBZ Dated: March 10, 2003 Received: March 13, 2003
Dear Mr. Johansen:
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. Johansen
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 (301) 594-4613. 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,
Susan Runov
Susan Runner, DDS, MA Interim 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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PRE-MARKET NOTIFICATION
INDIC ATIONS FOR USE
510(k) Number: __
Devic« Name: Cool Cure, dentil curing light and accessories
Indications for Use
The dialal curing light and accessories, Cool Cure, is used to provide a source of illumination for curing dental restorative matcrials in the mouth.
Concurrence of CDRH, Office of Device Evaluation
Prescription Use:
Over the Counter Use: (Pet 21 CFR 801.109)
Production of Mont Production A
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Keen Muly for NSR
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number: K030811
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§ 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.