Enlight LV is a light-cured, two component, orthodontic bonding adhesive and Enlight EV IS a light ourou, two con attachment of orthodontic appliances to teeth.

Device Description

The device is a visible light-cured, two component, orthodontic bonding adhesive. It is specifically designed to be used for the attachment of orthodontic appliances to teeth. The product has excellent handling characteristics, highly desirable curing properties and a high bond strength.

AI/ML Overview

The provided text is a 510(k) summary for a medical device called "Enlight LV," an orthodontic bracket adhesive and sealant. The document is a regulatory submission to the FDA, demonstrating substantial equivalence to a predicate device. It does not contain information about a clinical study, acceptance criteria, or performance data in the context of device efficacy or accuracy, which would be typical for an AI-powered diagnostic or predictive device.

Therefore, I cannot provide the requested information. The document focuses on regulatory approval based on demonstrating equivalence rather than a detailed performance study against acceptance criteria.

Summary

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JAN 2 1 1999

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SYBRON DENTAL SPECIALTIES

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

Submitter:

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

December 1998 Date Summary Prepared:

Device Name:

Trade Name - Enlight LV
Common Name Orthodontic Bracket Adhesive and Sealant ●
Classification Name Bracket Adhesive Resin and Tooth Conditioner, per 21 CFR § . 872.3750

Devices for Which Substantial Equivalence is Claimed:

Unitek Corporation/3M, Transbond Light Cure Orthodontic Adhesive .

Device Description:

Intended Use of the Device:

The intended use of Enlight LV is for the attachment of orthodontic appliances to teeth.

Substantial Equivalence:

Enlight LV is substantially equivalent to several other legally marketed devices in the United States. The orthodontic adhesive marketed by Unitek Corporation/3M functions in a manner similar to and is intended for the same use as the product manufactured by Ormco Corporation.

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Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's emblem, which consists of a stylized caduceus-like symbol with three wavy lines emanating from a central point. The emblem is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. The text is written in a sans-serif font and is evenly spaced around the emblem.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 2 1 1999

Ms. Colleen Boswell Senior Regulatory Affairs Specialist Sybron Dental Specialties, Incorporated 1717 W. Collins Avenue Orange, California 92867

Re : K984362 Trade Name: Enlight LV Regulatory Class: II Product Code: Dyn December 3, 1998 Dated: Received: December 7, 1998

Dear Ms. Boswell:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include reguirements 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in Please note: this response to your the Federal Reqister. premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Ms. Boswell

This letter will allow you to begin marketing your device as Info recei will as a (k) premarket notification. The FDA debting of substantial equivalence of your device to a legally marketed predicate device results in a classification for your markets promits your device to proceed to the market.

If you desire specific advice for your device on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in regaractor (21 devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact che office of Compliance at (301) 594-4639. Also, please note ene office or compitled, "Misbranding by reference to che regulation cheroids, "Illing and 1979", "Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

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

510(k) Number: K984362

Enlight LV Device Name:

Indications for Use:

Enlight LV is a light-cured, two component, orthodontic bonding adhesive and Enlight EV IS a light ourou, two con attachment of orthodontic appliances to teeth.

Susan Runa

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

Regulation Number and Section

§ 872.3750 Bracket adhesive resin and tooth conditioner.

(a)
Identification. A bracket adhesive resin and tooth conditioner is a device composed of an adhesive compound, such as polymethylmethacrylate, intended to cement an orthodontic bracket to a tooth surface.(b)
Classification. Class II.