Grengloo is a chromatic orthodontic bonding adhesive. Grengloo is designed specifically for use with metal brackets; however, bonding of all appliances including ceramic and plastic are indicated. This single paste bonding adhesive has a green color that enhances ease of use, specifically during bonding and post treatment adhesive remnant removal procedures. During treatment, the patient's body temperature is above the color transition temperature and the adhesive takes on the color of the enamel. Grengloo has very fast light cure properties and achieves high strength allowing active archwires to be placed immediately. Grengloo is compatible with traditional etching and sealant procedures, as well as newer self-etching techniques.

AI/ML Overview

This document is a 510(k) premarket notification for a new orthodontic bonding adhesive called "Grengloo." The submission focuses on demonstrating substantial equivalence to a previously cleared device (Blugloo) rather than providing detailed performance studies with acceptance criteria in the typical sense of a diagnostic or AI-driven device.

Therefore, the requested information elements related to acceptance criteria, detailed study design, sample sizes for test/training sets, ground truth establishment, expert involvement, and MRMC studies are not applicable or available within this provided document.

This document describes a medical device submission seeking market clearance based on substantial equivalence to a predicate device, not, a performance study with detailed acceptance criteria for a new clinical claim or an AI algorithm.

Here's a breakdown of why this information is not present in the provided text:

Nature of the Device: Grengloo is an orthodontic bonding adhesive, a material. Its "performance" is primarily assessed through material properties and clinical bonding success, not typically through diagnostic accuracy metrics like sensitivity or specificity that would have explicit acceptance criteria tables.
510(k) Premarket Notification: This type of submission (K061481) aims to demonstrate that a new device is as safe and effective as a legally marketed predicate device. This often relies on comparing material specifications, intended use, and general performance characteristics to the predicate, rather than extensive, new clinical trials against specific, quantitative acceptance criteria.
Lack of AI Component: The device is a physical adhesive, not an AI or diagnostic tool. Therefore, concepts like "test set," "training set," "ground truth experts," "adjudication," and "MRMC studies" are not relevant to its evaluation or the information typically required for its clearance.

In summary, the provided document does not contain the information requested because the device type (orthodontic bonding adhesive) and the regulatory submission pathway (510(k) for substantial equivalence) do not necessitate such detailed performance study reporting in the context of diagnostic AI tools.

Summary

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Image /page/0/Picture/0 description: The image shows a logo for Sybron Dental Specialties. The logo features the letters 'sds' in a stylized, bold font, with a curved line above them. Below the letters, the words 'SYBRON DENTAL SPECIALTIES' are printed in a simple, sans-serif font.

K061481

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

JUL - 6 2006

Submitter:

Sybron Dental Specialties, Inc. 100 Bayview Circle, Suite 6000 Newport Beach, California 92660 (949) 255-8766 - Phone (949) 255-8763 - Facsimile Colleen Boswell - Contact Person

Date Summary Prepared: May 2006

Device Name:

. Trade Name - Grengloo
. Common Name - Orthodontic Bonding Adhesive
. Classification Name - Bracket Adhesive Resin and Tooth Conditioner, per 21 CFR § 872.3750

Devices for Which Substantial Equivalence is Claimed:

. Sybron Dental Specialties, Inc., Blugloo

Device Description:

Intended Use of the Device:

The intended use of Grengloo is as a light-cured orthodontic bonding adhesive designed to be used for the attachment of orthodontic appliances to teeth.

Substantial Equivalence:

Grengloo is substantially equivalent to other legally marketed devices in the United States. Grengloo functions in a manner similar to and is intended for the same use as the product Blugloo cleared for marketing for Sybron Dental Specialties, Inc.

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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 and Human Services. The logo features a stylized representation of a human figure with three wavy lines emanating from it, enclosed within a circle. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES U.S.A." is arranged around the upper portion of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL - 6 2006

Ms. Colleen Boswell Director, Corporate Compliance Sybron Dental Specialties, Incorporated 100 Bayview Circle, Suite 6000 Newport Beach, California 92660

Re: K061481 Trade/Device Name: Grengloo . Regulation Number: 21 CFR 872.3750 Regulation Name: Bracket Adhesive Resin and Tooth Conditioner Regulatory Class: II Product Code: DYH Dated: May 25, 2006 Received: May 31, 2006

Dear Ms. Boswell:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). You may. therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions 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 (PMA). it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition. FDA mav publish further announcements concerning your device in the Federal Register.

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Page 2 - Ms. Colleen Boswell

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Dam 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Cyntti y michaels

Chiu S. Lin, PhD Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

11 061481

510(k) Number (if known):

Device Name: Grengloo

Indications For Use:

Grengloo is a light-cured orthodontic bonding adhesive and is intended to be used for the attachment of orthodontic appliances to teeth.

Prescription Use ﮯ (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use _ (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODF)


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Incu, General Hospital,
lian Control (Dental Devices	Page 1 of 1

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.