(57 days)
Enlight - 2 is a light-cured, two component, orthodontic bonding adhesive intended for attachment of orthodontic appliances to teeth.
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 provided text is a 510(k) Summary of Safety and Effectiveness for a medical device called "Enlight-2," an orthodontic bracket adhesive and sealant. This document focuses on demonstrating substantial equivalence to a predicate device for market clearance, rather than presenting a detailed study with acceptance criteria and device performance results as typically found in clinical trials or performance evaluations for AI/software-as-a-medical-device.
Therefore, most of the requested information regarding acceptance criteria, study design, expert involvement, and ground truth cannot be extracted from this document, as it is not a study report in that context. The clearance is based on the device being substantially equivalent to another legally marketed device, "Enlight," implying its formulation and intended use are similar enough not to raise new questions of safety and effectiveness.
Here's the available information based on your request categories:
1. A table of acceptance criteria and the reported device performance
- This document does not specify quantitative acceptance criteria or provide a table of reported device performance metrics. Its clearance is based on substantial equivalence to a predicate device, meaning its functional characteristics are considered similar enough to not warrant new, extensive performance testing data in the context of this 510(k) submission.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable. This document does not describe a clinical or performance study with a test set. This is a regulatory submission for substantial equivalence.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable. This document does not describe a study involving human experts establishing ground truth for a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable. This device is an orthodontic adhesive, not an AI-powered diagnostic or assistive tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a physical product (adhesive), not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable.
8. The sample size for the training set
- Not applicable. This document refers to the formulation of an adhesive, not a machine learning model.
9. How the ground truth for the training set was established
- Not applicable.
Summary from the document:
This 510(k) submission states that "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."
The "acceptance criterion" in this context is regulatory: demonstrating substantial equivalence to a predicate device (Ormco Corporation's "Enlight") that was already legally marketed in the US. The device performance is implicitly considered equivalent to the predicate based on its similar formulation and intended use. The FDA's letter (K984217) confirms this substantial equivalence determination.
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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.
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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.
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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
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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
§ 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.