(70 days)
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Not Found
No
The summary describes a device for cementing orthodontic brackets, with no mention of AI, ML, image processing, or data sets typically associated with AI/ML applications in medical devices.
No
The device is used for the cementation/affixing of orthodontic brackets, which are used to correct teeth alignment; the device itself does not directly treat a disease or condition.
No
The device's intended use is for "cementation/affixing of metal and/or ceramic orthodontic brackets to teeth," which is a treatment procedure, not a diagnostic one.
No
The provided text only describes the intended use of a device for cementing orthodontic brackets. It lacks any description of the device itself, particularly whether it is software or hardware. Without a device description, it's impossible to determine if it's a software-only medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "cementation/affixing of metal and/or ceramic orthodontic brackets to teeth." This is a direct application to the patient's body for a therapeutic purpose (orthodontic treatment).
- Lack of IVD Characteristics: IVDs are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The provided description does not mention any such use or interaction with bodily specimens.
Therefore, this device falls under the category of a medical device used for direct patient treatment, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
For the cementation/affixing of metal and/or ceramic orthodontic brackets to teeth.
Product codes
DYH
Device Description
Cool Bond Light Cured Bracket Adhesive System
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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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
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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.)
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Predicate Device(s)
Not Found
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/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is a symbol featuring three stylized human profiles facing to the right, with flowing lines beneath them, creating a sense of movement or connection.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 8 2002
Coltene AG C/O Mr. H.J. Vogelstein Coltene/Whaledent, Incorporated 750 Corporate Drive Mahwah, New Jersey 07430
Re: K022224
Trade/Device Name: Cool Bond Light Cured Bracket Adhesive System Regulation Number: 872.3750 Regulation Name: Bracket Adhesive Resin and Tooth Conditioner Regulatory Class: II Product Code: DYH Dated: July 8, 2002 Received: July 10, 2002
Dear Mr. Vogelstein:
This letter corrects our substantially equivalent letter of September 18, 2002 regarding the name of the Cool Bond Light Cured Bracket Adhesive System.
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 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). 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 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 may publish further announcements concerning your device in the Federal Register.
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Page 2 - Mr. Vogelstein
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 Part 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 continue 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 and additionally Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at their toll free number (800) 638-2041 or at (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Patricx Cuceritiffoc
Timothy A. Ulatowski Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
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Colliène ، (G, E :tablishment Reg. No. 961337
coltène r whaledent
K02224
510(k) Submission Cool Bond™ Light Cured Bracket Adhesive System Indications
For the cer nentation/affixing of metal and/or ceramic orthodontic brackets to teeth.
Susan Runne
(Division Sign-Off) (Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number: K182221