The Demi Ultra is a Light Emitting Diode (LED) visible light curing device used for the polymerization of light-cured materials by dental professionals.

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.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Demi Ultra device:

1. Table of Acceptance Criteria and Reported Device Performance

The provided submission does not explicitly list "acceptance criteria" in a quantitative, measurable format for the Demi Ultra. Instead, it relies on demonstrating substantial equivalence to a predicate device (Demi, K071251) through comparisons of technological characteristics and performance data. The implicit acceptance criterion is that the Demi Ultra performs comparably to the predicate device.

Characteristic / Performance Metric	Predicate Device (Demi - K071251)	Demi Ultra (Reported Performance)	Comparison / Implied Acceptance
Indications for Use	Polymerization of light-cured materials by dental professionals	Polymerization of light-cured materials by dental professionals	Equivalent
Light Source	LED	LED	Equivalent
Peak Wavelength	450-470nm	450-470nm	Equivalent
Wavelength range @ 50% (spectrum)	438-485nm	438-485nm	Equivalent
Typical Output Intensity (400-500nm, 8mm turbo light guide)	1100mW/cm² pulsed to 1330mW/cm²	1100mW/cm² pulsed to 1330mW/cm²	Equivalent
Biocompatibility	(Implied to be acceptable)	Passed (material manufacturer statements)	Accepted
Depth of Cure	(Implied to be acceptable)	Test data compared to predicate	Deemed comparable
Irradiance Data	(Implied to be acceptable)	Demonstrates light intensity and peak wavelength	Deemed acceptable
Software Validation	(Implied to be acceptable)	Successfully validated	Accepted

2. Sample Size and Data Provenance

Test Set Sample Size: Not explicitly stated. The submission mentions "depth of cure test data" and "irradiance data" for comparing the Demi Ultra to the predicate device, but does not provide details on the number of samples or trials used for these tests.
Data Provenance: The data appears to be from internal testing conducted by the manufacturer, Sybron Dental Specialties, Inc./Kerr Corporation. The country of origin is not specified but implicitly assumed to be where the company operates, likely the USA based on the submission to the FDA. The tests are retrospective in the sense that they were conducted by the manufacturer as part of the submission process, but the testing itself would be prospective for the evaluated device properties.

3. Number of Experts and Qualifications for Ground Truth

Not applicable. This device is an LED curing light, not an AI/ML diagnostic or prognostic device that requires expert adjudication of images or data to establish ground truth. The "ground truth" here is the physical performance characteristics of the device (light output, depth of cure, etc.) measured using scientific instruments and established protocols.

4. Adjudication Method for the Test Set

Not applicable, as this is not a study assessing human reader performance or requiring subjective interpretation. The performance characteristics are measured objectively.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a MRMC comparative effectiveness study was not done. This type of study is relevant for AI-assisted diagnostic or prognostic tools where human interpretation plays a significant role. The Demi Ultra is a medical device for polymerization of materials, not a diagnostic tool requiring interpretation by human readers.

6. Standalone Performance Study (Algorithm Only)

Not applicable directly in the AI/ML sense. However, the "Non-Clinical Test Data" section describes standalone performance evaluations of the Demi Ultra in terms of:

Biocompatibility: Materials designed to be in contact with a patient were tested and passed.
Depth of Cure: Data was collected to evaluate the Demi Ultra's performance.
Irradiance: Data was collected to demonstrate light intensity and peak wavelength.
Software Validation: The software was successfully validated to confirm device performance.

These can be considered standalone performance evaluations of the physical device and its embedded software. The performance was then compared to the predicate device.

7. Type of Ground Truth Used

The "ground truth" in this context refers to objectively measured physical and chemical properties:

Biocompatibility: Established through standard biocompatibility tests (e.g., ISO 10993 series) performed by material manufacturers.
Depth of Cure: Likely measured in a laboratory setting using standardized dental materials and techniques to assess the extent of polymerization.
Irradiance: Measured using radiometers or spectroradiometers to quantify light intensity and spectral distribution.
Software Functionality: Verified through validation testing against defined software requirements.

8. Sample Size for the Training Set

Not applicable. This device is not an AI/ML algorithm that learns from a training set of data. It is a hardware device with embedded software where performance is determined by its design and manufacturing.

9. How Ground Truth for the Training Set Was Established

Not applicable, as there is no "training set" for this type of device.

Summary

{0}------------------------------------------------

K123468

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

{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 CorporationThe Demi Ultra is a LightEmitting Diode (LED) visiblelight curing device used for thepolymerization of light-curedmaterials by dentalprofessionals.	Kerr CorporationThe Demi is a Light EmittingDiode (LED) visible light curingdevice used for thepolymerization of light-curedmaterials by dentalprofessionals.
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 powersource	No	Yes
Handpiece digital display	No (LED indicators)	No
User selectable curingmodes	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 8mmturbo light guide	1100mW/cm² pulsed to1330mW/cm²	1100mW/cm² pulsed to1330mW/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 CSAC22.2#60601-1	AAMI ES60601-1 and CSAC22.2#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

Section 004 - Page 2 of 2

Regulation Number and Section

§ 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.