ENLIGHT (TENTATIVE NAME)

K972890 · Sybron Dental Specialties, Inc. · DYH · Sep 16, 1997 · Dental

Device Facts

• Record ID: K972890
• Device Name: ENLIGHT (TENTATIVE NAME)
• Applicant: Sybron Dental Specialties, Inc.
• Product Code: DYH · Dental
• Decision Date: Sep 16, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3750
• Device Class: Class 2

Intended 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.

Device Story

Enlight is a visible light-cured orthodontic adhesive and sealant used by orthodontists to bond appliances to teeth. It consists of a single-component sealant and paste, replacing older chemically-cured systems that required manual mixing and had unpredictable working times. The device allows clinicians to position brackets accurately before curing with an intense visible light source for 10-20 seconds. It features fluoride release for caries protection during treatment and is available in syringe or Unidose delivery systems. The adhesive is applied in a clinical setting to facilitate orthodontic treatment, providing improved handling and convenience compared to traditional autocure materials.

Clinical Evidence

Bench testing only. Biocompatibility testing conducted per ISO 10993, including Cytotoxicity (Agarose Overlay), Mucosal irritation (rabbit vagina), and Dermal Contact sensitization (Guinea Pig). Efficacy demonstrated via side-by-side bench testing comparisons against predicate devices.

Technological Characteristics

Methacrylate ester monomer-based resin adhesive. Visible light-cured initiation system. Fluoride-releasing formulation. Available in syringe or Unidose delivery formats. Biocompatibility tested per ISO 10993 standards.

Indications for Use

Indicated for the attachment of orthodontic appliances to teeth in patients requiring orthodontic treatment.

Regulatory Classification

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.

Predicate Devices

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

Reference Devices

• Sequence (K914627)

Submission Summary (Full Text)

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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 [phone] - Phone [phone] - 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:

1. Ease of placement: optimized resin blend that exhibits supert handling characteristics.

2. Convenience: Both syringe and Unidse delivery systems are available.

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# Page 2 of 2

- 3. 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 )
- 2. Test Type: Mucosal irritation in the rabbit vagina.
- 3. 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 [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" (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 [phone] or [phone] 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 | |
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| Di | Control, |
| a | Devices |

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

| Prescription Use<br>(Per 21 CFR 801.109) | |
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