(73 days)
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No
The summary describes a bonding adhesive, a chemical substance, and contains no mention of AI, ML, image processing, or any computational elements.
No
The device is an adhesive used for bonding orthodontic appliances, which are therapeutic, but the adhesive itself does not directly provide therapy. It is a component used in a therapeutic process.
No
The device, Unite Bonding Adhesive, is an adhesive used for bonding orthodontic appliances to teeth. Its purpose is to facilitate orthodontic treatment, which is a structural or cosmetic modification, not a diagnostic process. It does not identify the presence or absence of a disease or condition.
No
The intended use clearly describes a bonding adhesive, which is a physical substance, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "bonding orthodontic appliances to teeth for orthodontic treatment." This is a direct application to the body (teeth) for a therapeutic purpose (orthodontic treatment).
- 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, etc.) to provide information for diagnosis, monitoring, or treatment.
IVD devices are specifically designed to be used in vitro (outside the body) to analyze biological samples. This device is used in vivo (on the body).
N/A
Intended Use / Indications for Use
Unite Bonding Adhesive is indicated for bonding orthodontic appliances to teeth for orthodontic treatment.
Product codes
DYH
Device Description
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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
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Intended User / Care Setting
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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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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 is a black and white circular logo for the U.S. Department of Health & Human Services. The logo features the department's emblem, which consists of a stylized caduceus-like symbol with three parallel lines curving upwards and to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper half of the circle, following its curvature.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 2 8 2002
Ms. L. Marlyn Scheff Regulatory Affairs Manager 3M Unitek 2724 South Peck Road Monrovia, California 91016
Re: K014142
Trade/Device Name: Unite Bonding Ashesive Regulation Number: 872.3750 Regulation Name: Orthodontic Adhesive Regulatory Class: II Product Code: DYH Dated: December 14, 2001 Received: December 17, 2001
Dear Ms. Scheff:
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 may publish further announcements concerning your device in the Federal Register.
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.
1
Page 2 - Ms. Scheff
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 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 and additionally 21 CFR 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Tim A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Statement of Indication for Use
510(k) Number:
Device Name:
Unite Bonding Adhesive
Indications For Use:
Unite Bonding Adhesive is indicated for bonding orthodontic appliances to teeth for orthodontic treatment.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Russe
(Division Sign-Off) ·vision of Dental, Infection Control, and General Hospital Devices 110(k) Number _ KQ14 140