(131 days)
Not Found
No
The description details a device with a digital circuit and microprocessor controlling basic functions (curing modes, charging, radiometer). There is no mention of AI, ML, image processing, or any learning/adaptive capabilities.
No
The device is used for the polymerization of light-cured materials by dental professionals, which is a functional task in dentistry rather than a therapeutic treatment for a health condition.
No
Explanation: The device is described as a "Light Emitting Diode (LED) visible light curing device used for the polymerization of light-cured materials" by dental professionals. Its function is to cure materials, not to diagnose conditions.
No
The device description clearly outlines hardware components including a handpiece, LED light curing attachment, charging dock, ultracapacitors, printed circuit boards, and an LED. While it mentions software for controlling modes and charging, it is an integral part of a physical device.
Based on the provided information, the Demi Ultra is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is for the polymerization of light-cured materials by dental professionals. This is a therapeutic/procedural use, not a diagnostic one.
- Device Description: The description details a light-curing device used to harden dental materials. It does not describe any components or functions related to analyzing biological samples (blood, urine, tissue, etc.) which is the core function of an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing samples, detecting biomarkers, or providing diagnostic information.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Demi Ultra's function is to cure dental materials within the patient's mouth, which is a direct treatment/procedure.
N/A
Intended Use / Indications for Use
The Demi Ultra is a Light Emitting Diode (LED) visible light curing device used for the polymerization of light-cured materials by dental professionals.
Product codes (comma separated list FDA assigned to the subject device)
EBZ
Device Description
The Demi Ultra is a Light Emitting Diode (LED) visible light curing device used for the polymerization of light-cured materials by dental professionals. The Demi Ultro consists of a handpiece, LED light curing attachment, and charging dock. The aluminum and plastic molded handpiece contains two (2) ultracapacitors (electric double-layer capacitors), printed circuit boards containing the electronics and user interface buttons, receptacle for retaining the LED light curing attachment, and receptacle for interfacing with the charging dock. The LED light curing attachment contains the curing LED, clear lens and two (2) copper head spreaders, all over molded in plastic. The charging dock contains printed circuit boards containing electronics to support charging the handpiece and built-in LED radiometer functionality. For the handpiece, a digital circuit and microprocessor is utilized to control three (3) different curing modes (5, 10 and 20 seconds). Each mode specifies LED curing output and optional audible beep timing. The handpiece uses one button to activate the LED curing output and another to select the curing time mode. For the charging dock, a digital circuit and microprocessor is utilized to monitor the charging of the handpiece ultracapacitors, as well as respond to light at the radiometer input by illuminating lights on a radiometer meter.
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 data is available on the material designed to be in contact with a patient. Included in this submission are statements from the material manufacturer indicating that samples from typical production lots were subjected to the biocompatibility tests and passed. This 510(K) submission also includes depth of cure test data used to evaluate the performance of the Demi Ultra as compared to the predicate device. Also included is irradiance data which demonstrates light intensity and peak wavelength. The Demi Ultra software has been successfully validated to confirm the performance of the device.
Clinical Test Data: Clinical testing has not been conducted on this product.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.
510(k) Summary
MAR 2 0 2013
Submitter:
Sybron Dental Specialties, Inc. 1717 West Collins Avenue Orange, California 92867 (714) 516-7484 - Phone (714) 516-7472 - Facsimile Colleen Boswell - Contact Person
Date Summary Prepared: November 2012
- . Trade Name – Demi Ultra
- Common Name ~ L.E.D. Curing Light
- Classification Name - Ultraviolet activator for polymerization, per 21 CFR 872.6070
- Product Codes – Ultraviolet activator for polymerization (EBZ)
Devices for Which Substantial Equivalence is Claimed:
- . Demi, Kerr Corporation, K071251
Device Description
The Demi Ultra is a Light Emitting Diode (LED) visible light curing device used for the polymerization of light-cured materials by dental professionals. The Demi Ultro consists of a handpiece, LED light curing attachment, and charging dock. The aluminum and plastic molded handpiece contains two (2) ultracapacitors (electric double-layer capacitors), printed circuit boards containing the electronics and user interface buttons, receptacle for retaining the LED light curing attachment, and receptacle for interfacing with the charging dock. The LED light curing attachment contains the curing LED, clear lens and two (2) copper head spreaders, all over molded in plastic. The charging dock contains printed circuit boards containing electronics to support charging the handpiece and built-in LED radiometer functionality. For the handpiece, a digital circuit and microprocessor is utilized to control three (3) different curing modes (5, 10 and 20 seconds). Each mode specifies LED curing output and optional audible beep timing. The handpiece uses one button to activate the LED curing output and another to select the curing time mode. For the charging dock, a digital circuit and microprocessor is utilized to monitor the charging of the handpiece ultracapacitors, as well as respond to light at the radiometer input by illuminating lights on a radiometer meter.
1
Indications for Use
The Demi Ultra is a Light Emitting Diode (LED) visible light curing device used for the polymerization of light-cured materials by dental professionals.
Summary of Technological Characteristics
| Descriptive Information | Demi Ultra | Demi (K071251) |
|---|---|---|
| Company | Kerr Corporation | |
| The Demi Ultra is a Light | ||
| Emitting Diode (LED) visible | ||
| light curing device used for the | ||
| polymerization of light-cured | ||
| materials by dental | ||
| professionals. | Kerr Corporation | |
| The Demi is a Light Emitting | ||
| Diode (LED) visible light curing | ||
| device used for the | ||
| polymerization of light-cured | ||
| materials by dental | ||
| professionals. | ||
| Indication for Use | ||
| Cordless | Yes | Yes |
| Light Source | LED | LED |
| Handpiece powersource | Ultracapacitor | Battery |
| AC supply connection | 100-240V AC, 1.0-0.5A, 50-60 Hz | 100-240V AC, 0.8-0.4A, 47-63 Hz |
| Operating time | 4 minutes | 50 minutes |
| Built-in radiometer | Yes | No |
| Microprocessor control | Yes (8-bit uc) | Yes (8-bit uc) |
| Power status indicator | Yes | Yes |
| Standard light guide | 8mm tapered | 8mm tapered |
| Reusable light guide | Yes | Yes |
| User replaceable power | ||
| source | No | Yes |
| Handpiece digital display | No (LED indicators) | No |
| User selectable curing | ||
| modes | Yes (5, 10 & 20 seconds) | Yes (5, 10 & 20 seconds) |
| Cooling fan | No | Yes |
| Audible beep | Yes | Yes |
| Continuous curing | Yes | Yes |
| Power source | Two (2) Ultracapacitors | Lithium Ion battery |
| Handpiece | Valox 357U | Valox 357U |
| Charging Base | Valox 357U | Valox 357U |
| Peak wavelength | 450-470nm | 450-470nm |
| Wavelength range @ 50% | ||
| (spectrum) | 438-485nm | 438-485nm |
| Typical output intensity: | ||
| 400-500nm, using 8mm | ||
| turbo light guide | 1100mW/cm² pulsed to | |
| 1330mW/cm² | 1100mW/cm² pulsed to | |
| 1330mW/cm² | ||
| Descriptive Information | Demi Ultra | Demi (K071251) |
| EMC | IEC66601--1-2:2007, EN 60601- | |
| 1-2:2007, and JIS T 0601-1- | ||
| 2:2012 | IEC66601-1-2:2001 | |
| Safety | AAMI ES60601-1 and CSA | |
| C22.2#60601-1 | AAMI ES60601-1 and CSA | |
| C22.2#60601-1 |
2
Non-Clinical Test Data
Biocompatibility data is available on the material designed to be in contact with a patient. Included in this submission are statements from the material manufacturer indicating that samples from typical production lots were subjected to the biocompatibility tests and passed.
This 510(K) submission also includes depth of cure test data used to evaluate the performance of the Demi Ultra as compared to the predicate device. Also included is irradiance data which demonstrates light intensity and peak wavelength.
The Demi Ultra 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 Demi Ultra software, the performance of the Demi Ultra is deemed to be substantially equivalent to the Demi.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle or bird symbol, with three curved lines representing the wings and body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 20, 2013
Kerr Corporation C/O Ms. Wendy Garman Director, Regulatory Affairs Sybron Dental Specialties, Incorporated 1717 West Collins Avenue ORANGE CA 92867
Re: K123468
Trade/Device Name: Demi Ultra Regulation Number: 21 CFR 872.6070 Regulation Name: Ultraviolet Activator for Polymerization Regulatory Class: II Product Code: EBZ Dated: January 3. 2013 Received: January 29, 2013
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. Iisting 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.
4
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,
Kwame O.
Ulmer
for
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known):
Device Name: Demi Ultro
Indications for Use:
The Demi Ultra is a Light Emitting Diode (LED) visible light curing device used for the The Demi Off a lo light-cured materials by dental professionals.
Prescription Use _ × (Part 21 CFR 801 Subpart D) AND/OR
iption Use
(21 CFR 801 Subpart D)
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) |
|---|
| -------------------------------------------------------- |
| Mary S. Runner - S |
|---|
| Susan Runner, USA |
| 2013.03.20 |
| 08:14:54'04'00 |
theslology, General Hospital
510(k) Number: K123458
.
Kerr Corporation - Demi Ultra - 510(k) Submission
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