← Product Code [DYH](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/DYH) · K984217 # ENLIGHT-2 (K984217) _Sybron Dental Specialties, Inc. · DYH · Jan 20, 1999 · Dental · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/DYH/K984217 ## Device Facts - **Applicant:** Sybron Dental Specialties, Inc. - **Product Code:** [DYH](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/DYH.md) - **Decision Date:** Jan 20, 1999 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 872.3750 - **Device Class:** Class 2 - **Review Panel:** Dental ## Intended Use The intended use of Enlight - 2 is for attachment of orthodontic appliances to teeth. ## Device Story Enlight-2 is a visible light-cured, two-component orthodontic bonding adhesive and sealant. It is used by dental professionals to attach orthodontic appliances to teeth. The device functions as a resin-based adhesive system. It is applied to the tooth surface and the appliance, then cured using a visible light source to secure the appliance in place. ## Clinical Evidence No clinical data provided; bench testing only. ## Technological Characteristics Visible light-cured, two-component orthodontic bonding adhesive and sealant. Resin-based chemistry. Classified as a bracket adhesive resin and tooth conditioner (21 CFR 872.3750). ## Regulatory 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 - Enlight (Ormco Corporation) ## Related Devices - [K984362](/device/K984362.md) — ENLIGHT LV · Sybron Dental Specialties, Inc. · Jan 21, 1999 - [K972890](/device/K972890.md) — ENLIGHT (TENTATIVE NAME) · Sybron Dental Specialties, Inc. · Sep 16, 1997 - [K094006](/device/K094006.md) — OPAL BOND MV · Ultradent Products, Inc. · Mar 23, 2010 - [K142880](/device/K142880.md) — DMRC Light Cure Orthodontic Adhesive System · Daville Materials, LLC · Feb 4, 2015 - [K022224](/device/K022224.md) — COOL BOND LIGHT CURED BRACKET ADHESIVE SYSTEM · Coltene AG · Sep 18, 2002 ## Submission Summary (Full Text) {0}------------------------------------------------ JAN 20 1999 Image /page/0/Picture/1 description: The image shows a handwritten sequence of numbers. The numbers are '984217'. The numbers are written in black ink on a white background. The handwriting is somewhat stylized, with the '8' being particularly loopy. # 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 Date Summary Prepared: November 1998 ### Device Name: - Trade Name Enlight 2 . - 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: - Ormco Corporation, Enlight . ### 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. ### Intended Use of the Device: The intended use of Enlight - 2 is for attachment of orthodontic appliances to teeth. ### Substantial Equivalence: Enlight - 2 is substantially equivalent to several other legally marketed devices in the United States. The modified formulation of Enlight functions in a manner similar to and is intended for the same use as the original Enlight formula currently manufactured by Ormco Corporation. {1}------------------------------------------------ Image /page/1/Picture/1 description: The image is a circular logo for the U.S. Department of Health & Human Services. The logo features the department's name encircling a stylized eagle symbol. The eagle is depicted with three curved lines forming its body and wings. The text is in all caps and arranged around the top and sides of the circle. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 JAN 20 1999 Ms. Colleen Boswell Senior Regulatory Affairs Specialist Sybron Dental Specialties, Incorporated 1717 W. Collins Avenue Orange, California 92867 Re: K984217 Trade Name: Enlight-2 Regulatory Class: II Product Code: DYH November 20, 1998 Dated: Received: November 24, 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 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations 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 regulatory action. In addition, FDA may publish further announcements 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 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations. {2}------------------------------------------------ Page 2 - Ms. Boswell 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 regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. 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, Timothy A. Ulatowski Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ Section I - Indications for Use 510(k) Number: K984217 Enlight - 2 Device Name: Indications for Use: Enlight - 2 is a light-cured, two component, orthodontic bonding adhesive intended Enlight - 215 a light ouroul, the forthodontic appliances to teeth. L. Alatorre A (Division Sign-Off) Division of Death, Infection Control, and General Hospital Devices 510(k) Number K984717 Prescription Device --- **Source:** [https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/DYH/K984217](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/DYH/K984217) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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