L.E.DEMETRON

K021797 · Sybron Dental Specialties, Inc. · EBZ · Jun 27, 2002 · Dental

Device Facts

• Record ID: K021797
• Device Name: L.E.DEMETRON
• Applicant: Sybron Dental Specialties, Inc.
• Product Code: EBZ · Dental
• Decision Date: Jun 27, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.6070
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The L.E.Demetron is a cordless LED curing light intended for polymerization of visible light cured materials.

Device Story

L.E.Demetron is a cordless LED curing light for dental material polymerization. Device components include a handheld unit with an LED light engine, cooling fan, rechargeable battery pack, and a digital circuit board; a battery charger with an integrated radiometer; and a remote handpiece holder. The operator selects from three curing modes via a pushbutton; a trigger switch activates the light. A segmented display shows the selected mode and timing. The integrated radiometer provides feedback on light output. Used in dental clinics by dental professionals to harden light-cured restorative materials, the device provides a portable, cordless solution for dental curing procedures.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Cordless LED curing light; molded plastic handpiece; LED light engine; cooling fan; rechargeable battery pack; digital circuit board for mode control; segmented display; integrated radiometer for light output measurement.

Indications for Use

Indicated for the polymerization of visible light cured dental materials.

Regulatory Classification

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

• 3M ESPE AG, Elipar FreeLight

Submission Summary (Full Text)

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JUN 2 7 2002

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 swooping line above them. Below the letters, the words 'SYBRON DENTAL SPECIALTIES' are written in a simple, sans-serif font.

K021797

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

Submitter:

Sybron Dental Specialties, Inc. 1717 West Collins Avenue Orange, California 92867 [phone] - Phone [phone] - Facsimile Colleen Boswell - Contact Person

May 2002 Date Summary Prepared:

#### Device Name:

- Trade Name L.E.Demetron .
- Common Name Cordless LED Curing Light .
- Classification Name Ultraviolet activator for polymerization, per 21 CFR § 872.6070 .

# Devices for Which Substantial Equivalence is Claimed:

- 3M ESPE AG, Elipar FreeLight .
# Device Description:

The L.E.Demetron Cordless Curing Light is a device used for the polymerization of dental materials using visible light. It consists of a cordless LED curing handpiece, a battery charger with built-in radiometer, and a remote handpiece holder. The plastic molded handpiece will contain a detachable rechargeable battery pack, an LED light "engine", and a cooling fan. A printed circuit board with a digital circuit will be utilized to control three (3) different curing modes. Each mode specifies LED timing, fan timing and audible beep timing. A segmented display will depict the curing mode and LED timing. A pushbutton switch will be used to scroll between the curing modes. A separate pushbutton "trigger switch" will activate the light. The molded plastic battery charger will have a single well for charging the battery pack, and indictor lights to indicate battery charge status. Indictor lights will also depict light output from the built-in radiometer.

# Intended Use of the Device:

The intended use of the L.E.Demetron is for the polymerization of visible light cured materials.

#### Substantial Equivalence:

L.E.Demetron is substantially equivalent to other legally marketed devices in the United States. L.E.Demetron functions in a manner similar to and is intended for the same use as the Elipar FreeLight designed by 3M ESPE AG.

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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 features the department's name encircling a stylized eagle emblem. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. The eagle is depicted with three stylized lines forming its head and wings.

Public Health Service

JUN 2 7 2002

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Colleen Boswell Director, Corporation Compliance Sybron Dental Specialties, Inc. 1717 West Collins Avenue Orange, California 92867

Re: K021797

Trade/Device Name: L.E.Demetron Regulation Number: 872.6070 Regulation Name: Ultraviolet Activator for Polymerization Regulatory Class: II Product Code: EBZ Dated: May 28, 2002 Received: May 31, 2002

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.

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.

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#### Page 2 - Ms. Colleen Boswell

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers. International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours

Timothy A. Ulatowski

Timothy A. Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Section I

Indications for Use Statement

Ver/3-4/24/96

Applicant: Kerr Corporation

510(k) Number (if known):

Device Name: L.E.Demetron

Indications For Use:

K021797

The *L.E.Demetron* is a cordless LED curing light intended for polymerization of visible light
cured materials.

(Division Sign-Off)
Division of Dental, Infection Control,
and General Hospital Devices
510(k) Number.
Ko21797

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF
NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Per 21 CFR 801.109)
(Optional Format 1-2-96)