← Product Code [EBZ](/productcode/EBZ) · K102621 # SOLSTICE (K102621) _Kerr Corporation · EBZ · Jan 28, 2011 · Dental · SESE_ **Canonical URL:** https://fda-staging.innolitics.com/device/K102621 ## Device Facts - **Applicant:** Kerr Corporation - **Product Code:** [EBZ](/productcode/EBZ.md) - **Decision Date:** Jan 28, 2011 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 872.6070 - **Device Class:** Class 2 - **Review Panel:** Dental - **Attributes:** Therapeutic ## Indications for Use The intended use of the Solstice is for the polymerization of light-cured materials by dental professionals. ## Device Story Solstice is a cordless, battery-operated LED curing light used by dental professionals to polymerize light-cured dental materials. The device consists of a plastic molded handpiece containing an LED light engine, a Lithium Iron Phosphate battery, and a printed circuit board. Unlike predicate devices that use light guides, Solstice features LEDs mounted directly at the tip of the unit. A microprocessor controls two curing modes (10 and 20 seconds) and audible beep timing, activated via a single pushbutton trigger. The device emits a constant light output, eliminating the need for a cooling fan. The healthcare provider uses the device to harden dental restorative materials, directly impacting the clinical workflow by providing a portable, consistent light source for dental procedures. ## Clinical Evidence No clinical data. Substantial equivalence is supported by bench testing, including biocompatibility studies on the handle resin, depth of cure testing, irradiance/wavelength measurements, and software validation. ## Technological Characteristics Cordless LED curing light; Lithium Iron Phosphate battery; tip-mounted LEDs; microprocessor-controlled curing modes (10s, 20s); constant light output; no cooling fan required. Plastic molded handpiece. Software-controlled timing and output. ## 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. ## Predicate Devices - Demi (Kerr Corporation) ## 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}------------------------------------------------ K102621 Image /page/0/Picture/1 description: The image shows a logo for Sybron Dental Specialties. The logo features the letters 'sds' in a stylized font, with a curved line above the letters. Below the letters, the words 'SYBRON DENTAL SPECIALTIES' are written in a simple, sans-serif font. The logo is black and white. JAN 2 8 2011 # Section III - 510(k) Summary of Safety and Effectiveness Submitter: Sybron Dental Specialties Inc. 1717 West Collins Avenue Orange, CA 92867 714-516-7602 - phone 714-516-7472- fax Wendy Garman - Contact Person Date Summary Prepared: September 2010 #### Device Name: - . Trade Name - Solstice - . Common Name - L.E.D. Curing Light - Classification Name Ultraviolet activator for polymerization, per 21 § CFR 872.6070 . # Devices for Which Substantial Equivalence is claimed: - . Kerr Corporation, Demi #### Device Description: The Solstice is a Light Emitting Diode (LED) visible light used for the polymerization of light-cured materials by dental professionals. The Solstice consists of an LED curing handpiece and a charging system. The plastic molded handpiece contains an LED light engine, battery, and printed circuit board containing the electronics. A digital circuit and microprocessor will be utilized to control two (2) different curing modes (10 and 20 seconds). Each mode specifies LED curing output and audible beep timing. The Solstice uses a single pushbutton trigger to activate the LED curing output and select the curing mode. #### Intended Use of the Device: The intended use of the Solstice is for the polymerization of light-cured materials by dental professionals. # Substantial Equivalence: The Solstice is substantially equivalent to one other legally marketed device in the United States. The Solstice functions in a manner similar to and is intended for the same use as the Demi, manufactured by Kerr Corporation. {1}------------------------------------------------ The Solstice is similar to the Demi in that it is a cordless battery-operated device, uses LED as the light source, and has user-selectable curing modes. The Solstice differs from the Demi in that the Solstice does not utilize a light guide to direct the light from the body of the light guide, but rather the LEDs are mounted at the tip of the unit. The Solstice does not require a cooling fan, as demonstrated by temperature data which has been included in this submission. The Solstice uses a Lithium Iron Phosphate battery, as opposed to the Lithium lon battery of the Demi. Unlike the Demi, which during use shifts light output intensity from 1100mW/cm- to 1300mW/cm-multiple times throughout the curing cycle, the Solstice emits a constant light output. #### Non-Clinical Test Data: Biocompatibility studies have been conducted on a representative resin similar to the resin used to produce the handle of the Solstice (the only difference is the color). Included in this submission is a statement from the component manufacturer indicating that samples from typical production lots of the resin were subjected to the biocompatibility tests and passed. This 510(K) submission also includes depth of cure testing data used to evaluate the performance of the Solstice compared to the predicate device. Also included is irradiance data which demonstrates light intensity and peak wavelength. The Solstice software has been successfully validated to confirm the performance of the device. # Clinical Test Data: Clinical testing has not been conducted on this product. #### Conclusion: Based upon the biocompatibility studies, similar technological/performance characteristics as compared to the predicate device, and successful validation of the Solstice software, the clinical performance of the Solstice is deemed to be substantially equivalent to the Demi. {2}------------------------------------------------ ### DEPARTMENT OF HEALTH & HUMAN SERVICES Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002 Kerr Corporation C/O Ms. Wendy Garman Sybron Dental Specialties 1717 West Collins Avenue Orange, California 92867 JAN 2 8 2511 Re: K102621 Trade/Device Name: Solstice Regulation Number: 21 CFR 872.6070 Regulation Name: Ultraviolet Activator for Polymerization Regulatory Class: II Product Code: EBZ Dated: January 21, 2011 Received: January 24, 2011 Dear Ms. Garman: 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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. : {3}------------------------------------------------ # Page 2- Ms. Garman 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820): and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801). please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. 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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Sincerely yours, ري ڪري جي جي جي جي جي جي جي جي جي جي جي جي جي جي جي جي جي جي جي جي جي جي جي جي جي جي جي جي جي جي جي جي جي جي جي جي جي جي جي جي جي جي جي جي جي جي جي جي جي جي جي جي جي جي جي ج Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health {4}------------------------------------------------ # Indications for Use # 510(k) Number (if known): K |(2 Device Name: Solstice #### Indications for Use: The intended use of the Solstice is for the polymerization of light-cured materials by dental professionals. Prescription Use (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 807 Subpart C) (Please DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) (Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices 510(k) Number: 150262 Page 1 of 1 --- **Source:** [https://fda-staging.innolitics.com/device/K102621](https://fda-staging.innolitics.com/device/K102621) **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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