(37 days)
Not Found
No
The description focuses on the physical and chemical properties of the adhesive, its color-changing feature based on temperature, and its bonding characteristics. There is no mention of any computational analysis, algorithms, or learning processes that would indicate the use of AI or ML.
No
Grengloo is used to attach orthodontic appliances to teeth and does not provide therapy itself; it is a bonding adhesive.
No
The device is an adhesive used for attaching orthodontic appliances to teeth, not for diagnosing conditions. Its description focuses on its properties for bonding and removal, not on detecting or identifying diseases or conditions.
No
The device description clearly states that Grengloo is a "light-cured orthodontic bonding adhesive," which is a physical material, not software.
Based on the provided information, Grengloo is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is for the attachment of orthodontic appliances to teeth. This is a direct application to the body for a therapeutic purpose (orthodontic treatment).
- Device Description: The description focuses on the physical properties of the adhesive (light-cured, chromatic, strength, cure time) and its application in bonding brackets to teeth.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
IVD devices are used outside the body to analyze samples and provide diagnostic information. Grengloo is used on the body for a treatment procedure.
N/A
Intended Use / Indications for Use
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.
Grengloo is a light-cured orthodontic bonding adhesive and is intended to be used for the attachment of orthodontic appliances to teeth.
Product codes
DYH
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
teeth
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Sybron Dental Specialties, Inc., Blugloo
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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.
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:
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.
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.
2
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
3
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)
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