The Demi is a Light Emitting Diode (LED) visible light curing unit used for the polymerization of light-cured materials by dental professionals. The Demi consists of an LED curing handpiece and charging system. The plastic molded handpiece will contain an LED light "engine", a cooling fan and a printed circuit board. A digital circuit and microprocessor will be utilized to control three (3) different curing modes (5, 10 and 20 seconds). Each mode specifies LED curing output, fan, and audible beep timing. The Demi utilizes two pushbutton triggers, one to select the curing mode and another to activate the LED curing output.

AI/ML Overview

This document describes a 510(k) premarket notification for a dental device, the Demi LED Curing Light. It does not contain information about acceptance criteria, device performance studies, or AI/ML evaluations. Therefore, I cannot generate the requested table and study details.

The provided text focuses on:

Device Identification: Trade Name (Demi), Common Name (L.E.D. Curing Light), Classification Name (Ultraviolet activator for polymerization).
Intended Use: Polymerization of visible light-cured materials by dental professionals.
Substantial Equivalence: Claims substantial equivalence to the Kerr Corporation, L.E. Demetron II.
FDA Communication: Official letter from the FDA confirming review and substantial equivalence determination, allowing the device to be marketed.

To fulfill your request, I would need a different type of document that details performance testing, clinical study results, or AI/ML validation data.

Summary

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Image /page/0/Picture/0 description: The image shows a logo with the letters 'sds' in a stylized font. A curved line extends over the letters. The letters are bold and black. The logo appears to be for a dental practice.

K071251

SYBRON DENTAL SPECIALTIES

JUL 26 2007

Section III - 510(k) Summary of Safety and Effectiveness

Submitter:

Sybron Dental Specialties, Inc. 1717 West Collins Avenue Orange, California 92867 (714) 516-7484 - Phone (714) 516-7488 - Facsimile Colleen Boswell - Contact Person

Date Summary Prepared: May 2007

Device Name:

Trade Name Demi .
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, L.E. Demetron II

Device Description:

Intended Use of the Device:

The intended use of Demi is for the polymerization of visible light-cured materials by dental professionals.

Substantial Equivalence:

Demi is substantially equivalent to other legally marketed devices in the United States. Demi functions in a manner similar to and is intended for the same use as the L.E. Demetron II designed by Kerr Corporation.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 26 2007

Kerr Corporation C/O Ms. Colleen Boswell Vice President, Regulatory Affairs Sybron Dental Specialties, Incorporated 1717 West Collins Avenue

Re: K071251

Orange, California 92867

Trade/Device Name: Demi Regulation Number: 872.6070 Regulation Name: Ultraviolet Activator for Polymerization Regulatory Class: II Product Code: EBZ Dated: June 25, 2007 Received: June 26, 2007

Dear Ms. Boswell:

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.

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Page 2 - Ms. Boswell

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 (240) 276-0115. 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/industry/support/index.html.

Sincerely vours.

Sudite 4. Michael MD.

Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known):

Device Name: Demi

Indications for Use:

The Demi is an L.E.D. visible light curing unit intended for polymerization of light cure 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)

signature

(Section Sign-Off)
Division of Anesthesiology, General Hospital,
Infection Control, Dental Devices	Page 1 of 1
510(k) Number:	K071251

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.