OPTILUX CURING LIGHTS

K020267 · Sybron Dental Specialties, Inc. · EBZ · Mar 29, 2002 · Dental

Device Facts

• Record ID: K020267
• Device Name: OPTILUX CURING LIGHTS
• Applicant: Sybron Dental Specialties, Inc.
• Product Code: EBZ · Dental
• Decision Date: Mar 29, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.6070
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Optilux Curing Lights are visible light curing units intended for polymerization of light cure materials.

Device Story

Optilux Curing Lights (Models 380, 401, 405) are dental devices for polymerizing light-cure materials. System comprises a molded plastic control unit and a cord-connected handpiece. Handpiece contains a low-voltage halogen lamp, optical filter assembly, and fiber optic light guide; generates blue-white visible light (400-515 nm). Operation involves manual activation via a micro-switch on the handpiece. Model 380 includes integrated radiometer circuitry. Used by dental professionals in clinical environments to harden dental restorative materials. Benefits include efficient, controlled polymerization of light-activated dental resins.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Molded plastic housing; low-voltage halogen lamp; optical filter assembly; fiber optic light guide; bandwidth 400-515 nm; printed circuit board control circuitry; cooling fan; Model 380 includes integrated radiometer; corded handpiece; electrical power source.

Indications for Use

Indicated for the polymerization of light-cured dental materials in a clinical setting.

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

• Kerr Corporation, Optilux 400

Submission Summary (Full Text)

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MAR 2 9 2002

120267

# SYBRON DENTAL SPECIALTIES

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

Date Summary Prepared: January 2002

#### Device Name:

- Trade Name Optilux Curing Lights .
- Common Name Curing Light .
- . Classification Name - Ultraviolet activator for polymerization, per 21 CFR & 872.6070

#### Devices for Which Substantial Equivalence is Claimed:

- . Kerr Corporation, Optilux 400
#### Device Description:

The Optilux Curing Lights, Models 380, 401 and 405, are devices used for the polymerization of dental materials using visible light. They consist of a control unit and cord connected handpiece. The molded plastic control units house the printed circuit board with control circuitry for the lamp and cooling fan. Additionally, the printed circuit board for the Model 380 contains control circuitry for radiometer functions. Model 380 also has a permanently attached power cord, however the power cords on Models 401 and 405 are detachable. The handpiece cord attached to the Model 405 is separable by a panel mount connector, which allows the control unit to be installed inside a cabinet or dental chair.

The molded plastic handpieces contain a low voltage halogen lamp, optical filter assembly and a fiber optic light guide that generates visible (blue-white) light energy having a bandwidth of approximately 400 - 515 nm. The handpieces also contain a small printed circuit board with a micro-switch for activation of the curing lamp.

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# Intended Use of the Device:

The intended use of the Optilux Curing Lights are for the polymerization of light cure materials.

# Substantial Equivalence:

The Optilux Curing Lights are substantially equivalent to other legally marketed devices in the United States. The Optilux Curing Lights function in a manner similar to and are intended for the same use as the Optilux 400 designed by Kerr Corporation.

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of three abstract figures, possibly representing people, with flowing lines suggesting movement or connection.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 .

# MAR 2 9 2002

Ms. Colleen Boswell Director, Corporate Compliance Sybron Dental Specialties, Incorporated 1717 West Collins Avenue Orange, California 92667

Re: K020267

Trade/Device Name: Optilux Curing Lights Regulation Number: 872.6070 Regulation Name: Ultaviolet Activator for Polymerization Regulatory Class: II Product Code: EBZ Dated: January 22, 2002 Received: January 25, 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. 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,

Patricia Cucentiffor

Timothy A. Ulatowski 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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K020267

# Section I

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Indications for Use Statement

| Ver/3 - 4/24/96 | |
|---------------------------|-----------------------|
| Applicant | Kerr Corporation |
| 510(k) Number (if known): | |
| Device Name: | Optilux Curing Lights |
| Indications For Use: | |

The Optilux Curing Lights are visible light curing units intended for polymerization of light cure materials.

Susan Rinn

(Division Sign-Off)

Division of Dental, Infection Control, and General Hospital Devices

| 510(k) Number | K020267 |
|---------------|---------|
|---------------|---------|

(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)