The Optilux 501 is a device used for the polymerization of dental materials using visible light. It consists of a control unit and cord connected hand piece. The molded plastic control unit contains a power inlet receptacle for a detachable mains power cord, fuse holders and fuses, mains wiring, mains supply isolation transformer, printed circuit board with control circuitry for lamp and cooling fan functions and an integrated curing radiometer. The cord connected molded plastic hand piece contains a low voltage halogen lamp, optical filter assembly and fiber optic light guide that generates visible (blue-white) light energy having the wavelength range of approximately 400nm -505 nm. The hand piece also contains a small printed circuit board with a micro-switch for activation of the curing lamp.

AI/ML Overview

The provided text does not contain information about acceptance criteria or a study proving the device meets said criteria. The document is a 510(k) premarket notification for the Optilux 501 curing light, focusing on its substantial equivalence to a previously marketed device (Optilux 400).

The relevant sections describe:

Device Name: Optilux 501 (Trade Name), Curing Light (Common Name)
Device Description: A control unit and cord-connected hand piece used for polymerization of dental materials with visible light (400nm - 505nm). It includes a halogen lamp, optical filter, and fiber optic light guide.
Intended Use: Polymerization of light cure materials and activation of dental bleaching materials.
Substantial Equivalence: Claimed to be substantially equivalent to the Optilux 400, functioning similarly and having the same intended use.
FDA's 510(k) Determination: The FDA reviewed the notification and determined the device is substantially equivalent to legally marketed predicate devices.

Therefore, I cannot populate the table or provide information about acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth for training/test sets because this data is not present in the provided text.

The document is a regulatory approval letter based on substantial equivalence, not a performance study report with detailed acceptance criteria and validation results.

Summary

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K0 20091

Image /page/0/Picture/1 description: The image shows the 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 printed in a simple font. The words 'Safety and Effectiveness' are printed below the company name.

MAR 2 1 2002

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:

January 2002

Device Name:

Trade Name Optilux 501 .
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:

Intended Use of the Device:

The intended use of the Optilyx 501 is for the polymerization of light cure materials and activation of dental bleaching materials.

Substantial Equivalence:

Optilux 501 is substantially equivalent to other legally marketed devices in the United States. Optilux 501 functions in a manner similar to and is intended for the same use as the Optilux 400 designed by Kerr Corporation.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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 graphic of an eagle or bird-like figure with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" is arranged in a circular fashion around the graphic.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 1 2002

Kerr Corporation Ms. Colleen Boswell C/O Sybron Dental Specialties, Incorporated 1717 West Collins Avenue Orange, California 92867

Re: K020091

Trade/Device Name: Optilux 501 Regulation Number: 872.6070 Regulation Name: Curing Light Regulatory Class: II Product Code: EBZ Dated: January 7, 2002 Received: January 10, 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 a!l 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 (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,
K. Walorski

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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Section I

Indications for Use Statement

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Applicant: Kerr Corporation

Labels	Values
510(k) Number (if known):	Ko 20091

Device Name: Optilux 501

Indications For Use:

The Optilux 501 is a visible curing unit intended for polymerization of light cure materials and activation of dental bleaching materials.

Susan Runpa

sion Sign-Off)
sion of Dental, Infection Control,
General Hospital Devices

Labels	Values
k) Number	R02009)

(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

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.