Ormco Enlight is a single component sealant and single component paste, visible light cured orthodontic bonding adhesive indicated for the attachment of orthodontic appliances to teeth.

Device Description

Ormco's Enlight is designed to fulfill all of the requirements of a successful orthodontic adhesive. These requirements are itemized below: 1. Ease of placement: optimized resin blend that exhibits supert handling characteristics. 2. Convenience: Both syringe and Unidse delivery systems are available. 3. Enlight provides flouride release for caries protection during the orthodontic treatment period.

AI/ML Overview

The provided text describes a 510(k) submission for the "Ormco Enlight Orthodontic Adhesive" and its claimed substantial equivalence to predicate devices. However, the document does not contain a typical acceptance criteria table with specific performance metrics (e.g., sensitivity, specificity, accuracy) or the detailed results of a study designed to prove the device meets such criteria in a quantitative, statistical manner as typically expected for modern medical device clearances.

Instead, the submission focuses on biocompatibility and efficacy in a more general sense, claiming the device "performs as well or better than the predicate devices currently on the market" based on "in-house testing and side by side test comparisons."

Given the limitations of the provided text, I will extract and present the information as best as possible, acknowledging where specific requested details are not available.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criterion Type	Acceptance Criteria (Specific Metrics)	Reported Device Performance
Biocompatibility	Safety as recommended by ISO 10993 guidance standard	- Cytotoxicity Study (Agarose Overlay): Passed (tested by independent lab)
		- Mucosal Irritation (Rabbit Vagina): Passed (tested by independent lab)
		- Dermal Contact Sensitization (Guinea Pig): Passed (tested by independent lab)
Efficacy (General)	Performs as well or better than predicate devices	Results of "bench testing" indicate the device "performs as well or better than the predicate devices currently on the market." (No specific metrics or quantitative comparison results provided).
Handling Characteristics	Optimized resin blend exhibiting superb handling characteristics	Claimed to have an optimized resin blend with "superb handling characteristics." (Qualitative claim, no specific metric given).
Convenience	Availability of delivery systems	Both syringe and Unidose delivery systems are available. (Refers to feature availability).
Fluoride Release	Provides fluoride release	Claims to provide fluoride release for caries protection. (Qualitative claim, no specific release rate or duration provided).

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: Not specified for any of the efficacy (bench testing) or biocompatibility tests. The document only mentions "cured samples" for biocompatibility and "in-house testing and side by side test comparisons" for efficacy.
Data Provenance:
- Efficacy: "in-house testing" (presumably conducted by the submitter, Ormco)
- Biocompatibility: "independent laboratory which specializes in safety and toxicity evaluation"
- Geographic Origin: Not specified but given the submitter's location (Orange, CA) and FDA submission, it implies a US regulatory context.
- Retrospective/Prospective: Not specified, but bench testing and independent lab biocompatibility tests are typically prospective.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

This information is not provided in the document. For biocompatibility, the ground truth is established by the test results themselves based on recognized standards (ISO 10993). For efficacy, the "ground truth" seems to be the performance of predicate devices, but the method of comparison and expert involvement is not detailed.

4. Adjudication Method for the Test Set

This information is not provided. Given the nature of bench testing and biocompatibility tests, formal adjudication rounds as seen in clinical image analysis studies are generally not applicable.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. The efficacy section mentions "side by side test comparisons to predicate devices" and "bench testing," which are not MRMC studies. The document does not describe human readers, AI assistance, or an effect size for human improvement.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This question is not applicable as the device is an orthodontic adhesive, not an AI algorithm.

7. The Type of Ground Truth Used

Biocompatibility: Ground truth is based on the results of standardized biological tests (Cytotoxicity, Mucosal Irritation, Dermal Contact Sensitization) conforming to ISO 10993 guidance.
Efficacy: The ground truth for comparison is the performance of "predicate devices currently on the market" (specifically Unitek Transbond and Light-Bond). The specific metrics constituting this performance ground truth are not detailed.

8. The Sample Size for the Training Set

This question is not applicable as the device is an orthodontic adhesive, not an AI algorithm requiring a training set in the machine learning sense. The formulation would have undergone R&D and optimization, but this isn't a "training set" in the context of AI.

9. How the Ground Truth for the Training Set Was Established

This question is not applicable for the same reason as point 8. The "ground truth" during development would be the desired performance characteristics (e.g., bond strength, cure time, handling properties) established through internal research and development criteria based on industry standards and market needs.

Summary

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SFP | 6 1997

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510 ( k ) Summary

Statement of Safety an Effectiveness

Ormco Enlight Orthodontic Adhesive

Submitter

Sybron Dental Specialties Inc. 1717 West Collins Avenue Orange, CA 92867 (714) 516-7486 - Phone (714) 516-7488 - FAX William R. Pike - Contact Person

Device Name

Trade Name: Enlight ( Tentative Name ) Common Name: Visible Light Cured Orthodontic Bracket Adhesive and Sealant Classification Name; DYH DE(76) Adhesive, Bracket and Tooth Conditioner, Resin Class II

Devices for which Substantial Equivalence is Claimed

Unitek Transbond ( 3M ) and Light - Bond ( Reliance Orthodontic Products, Inc. )

BACKGROUND

Methacrylate ester monomer based adhesives have been used successfully for over thirty years to bond appliances to teeth during orthodontic treatment procedures. Early examples of these products were chemically cured ( autocure ) materials that required the mixing of a catalyst and base resin by the orthodontist immediately prior to positioning the bracket on the tooth. Because the working time of these materials was so unpredictable due to the effects of temperature and aging, many times the orthodontist would have to reposition the appliance and repeat the bonding process.

In 1992, Ormco Corportation introduced a product, "Sequence" (FDA Reference No. K914627) that employed a visible light curing initiation system for curing. Sequence was not time dependent and allowed the orthodontist to correctly position the bracket before curing with a 10 -20 second exposure to intense visible light. It is the next generation of visible light curing orthodontic adhesives that is the subject of this 510 ( k ) submission.

Enlight Orthodontic Adhesive and Sealant

Ormco's Enlight is designed to fulfill all of the requirements of a successful orthodontic adhesive. These requirements are itemized below:

Ease of placement: optimized resin blend that exhibits supert handling characteristics.
Convenience: Both syringe and Unidse delivery systems are available.

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1. Enlight provides flouride release for caries protection during the orthodontic treatment period.

SAFETY

The safety of Ormco Enlight adhesive has been demonstrated by subjecting cured samples of the material to three biocompatibility tests as recommended in the ISO 10993 biocompatibility guidance standard. This testing was conducted by an independent laboratory which specializes in safety and toxicity evaluation.

1. Test Type: Cytotoxicity Study ( Agarose Overlay )
1. Test Type: Mucosal irritation in the rabbit vagina.
1. Test Type: Dermal Contact sensitization ( Guinea Pig )

EFFICACY

Effectiveness or suitability to the intended purpose of Enlight has been demonstrated by a combination of in-house testing and side by side test comparisons to predicate devices currently on the market. Results of this bench testing indicates that Orthodontic Adhesive performs as well or better than the predicate devices currently on the market

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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three lines forming its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The text is in all capital letters.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 1 6 1997

Mr. William R. Pike Requlatory Affairs Specialist Sybron Dental Specialities, Incorporated 1717 W. Collins Avenue Orange, California 92667

Re: K972890 Enlight (Tentative Name) Trade Name: Requlatory Class: II Product Code: DYH Dated: July 30, 1997 Received: August 5, 1997

Dear Mr. Pike:

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 abe beach in the 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, Druq, 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 requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions aqainst 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 Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic (OS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531

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Page 2 - Mr. Pike

through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. 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" (21 CFR 807.97). 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,

Patricia Cucurullo Hor

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

Enclosure

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510(k) Number: K972890

Device Name : Enlight Orthodontic Bracket Adhesive

Indications For Use : Ormco Enlight is a single component sealant and single component paste, visible light cured orthodontic bonding adhesive indicated for the attachment of orthodontic appliances to teeth.

(Divi
Di	Control,
a	Devices

(Division Sign-Off)
Division of Dental, Infection Control, and General Hospital Devices
510(k) Number	K972890

Prescription Use(Per 21 CFR 801.109)
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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.