(137 days)
Not Found
No
The description details a simple LED curing light with a microprocessor controlling pre-defined curing modes based on time. There is no mention of AI/ML terms, image processing, or data-driven decision making.
No
The device is used for the polymerization of light-cured materials, which is a process within dentistry, but it does not directly treat a disease or condition in a patient.
No
The device is used for the polymerization of light-cured materials, which is a treatment or procedural function, not a diagnostic one. It solidifies materials, it does not identify or analyze a condition.
No
The device description explicitly states it consists of an LED curing handpiece and a charging system, both of which are hardware components. It also describes the physical construction of the handpiece including an LED light engine, battery, and printed circuit board.
Based on the provided information, the Solstice device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "for the polymerization of light-cured materials by dental professionals." This describes a therapeutic or procedural use, not a diagnostic one.
- Device Description: The description details a light-emitting device used to cure materials, which aligns with a dental procedure, not an in vitro diagnostic test.
- Lack of IVD Characteristics: The description does not mention any components or functions related to analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information about a patient's health status.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Solstice device is used in vivo (on the patient) to cure dental materials.
N/A
Intended Use / Indications for Use
The intended use of the Solstice is for the polymerization of light-cured materials by dental professionals.
Product codes
EBZ
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
dental professionals
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Kerr Corporation, Demi
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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.
:
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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
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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
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