← Product Code [EBZ](/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/EBZ) · K030811 # COOL CURE (K030811) _Samm, Inc. · EBZ · Jun 10, 2003 · Dental · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/EBZ/K030811 ## Device Facts - **Applicant:** Samm, Inc. - **Product Code:** [EBZ](/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/EBZ.md) - **Decision Date:** Jun 10, 2003 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 872.6070 - **Device Class:** Class 2 - **Review Panel:** Dental - **Attributes:** Therapeutic ## Intended 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. ## Device Story Cool Cure is a dental curing light used by dental professionals to polymerize restorative materials in the mouth. Device provides illumination to initiate curing process. Used in clinical dental settings. Benefits include efficient hardening of dental composites and restorative materials. ## Clinical Evidence No clinical data provided; bench testing only. ## Technological Characteristics Dental curing light; utilizes light energy for polymerization of restorative materials. Class II device, product code EBZ. ## Regulatory 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) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines forming its body and wings. The eagle is enclosed within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is written around the circumference of the circle. 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. {1}------------------------------------------------ ## 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 {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows a handwritten string of characters. The characters appear to be a combination of letters and numbers. The string starts with the letter 'K', followed by the letter 'U', then the number '3', the number '0', the number '8', and finally the number '11'. ## 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 .. . . . . . . . . Keen Muly for NSR (Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices 510(k) Number: K030811 . ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ : : : . :. --- **Source:** [https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/EBZ/K030811](https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/EBZ/K030811) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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