(99 days)
Not Found
Not Found
No
The provided 510(k) summary describes a dental bonding agent and does not mention any AI or ML technology in its intended use, device description, or performance studies.
No.
The device is described as bonding material for restorative dentistry, which does not directly treat or cure a disease or condition.
No
The device is described as a bonding agent used in restorative dentistry for various materials like dentin, enamel, porcelain, metal, and composite. Its function is to bond materials, not to diagnose a condition or disease.
No
The 510(k) summary describes a bonding agent used in restorative dentistry, which is a physical material, 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 in restorative dentistry, specifically for bonding to teeth (dentin and enamel), porcelain, metal, and composite. This is a direct application within the body (or on materials that will be placed in the body), not for testing samples taken from the body.
- Anatomical Site: The anatomical site is dentin and enamel, which are parts of the human body.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting diseases, or providing diagnostic information based on biological samples.
IVDs are devices used to examine specimens derived from the human body to provide information for the diagnosis, prevention, or treatment of a disease or condition. This device's function is purely for bonding materials in a dental restoration process.
N/A
Intended Use / Indications for Use
Indication For Use: for almost all bonding needs in restorative dentistry. Bonds chemical cure luting and chemical cure connosites, namely PermaFlo DC, also bonds to light cured PermaQuick SE. PermaQuick SE docs not recuire a separate etching step for quality adhesion. PermaQuick SE is conducive for bonding to:
- Dentin and Enamel using composite or amalgam
- Porcelain
- Metal
- Composite repair
Product codes
KLE
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
Dentin and Enamel
Indicated Patient Age Range
Not Found
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
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)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.3200 Resin tooth bonding agent.
(a)
Identification. A resin tooth bonding agent is a device material, such as methylmethacrylate, intended to be painted on the interior of a prepared cavity of a tooth to improve retention of a restoration, such as a filling.(b)
Classification. Class II.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines representing the wings and body.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC - 3 2003
Ultradent Products, Incorporation Mr. Peter Allred R&D Manager 505 West 10200 South South Jordan, Utah 84095
Re: K032626
Trade/Device Name: PermaQuick SF Bonding System Regulation Number: 872.3200 Regulation Name: Resin tooth Bonding Agent Regulatory Class: II Product Code: KLE Dated: August 22, 2003 Received: September 9, 2003
Dear Mr. Allred:
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.
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Page 2 - Mr. Allred
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 modi that I Dr mai made 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 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 (301) 594-4613. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Susan Bunner
Chiu Lin. Ph.D. 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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Page 1 of
Ko32626
510(k) Number (if known): Unknown
PermaQuick SE Bonding System Device Name: ________
Indications For Use:
Us : for almost all bonding needs in restorative dentistry. Bonds chemical cure luting and chemical cure connosites, namely PermaFlo DC, also bonds to light cured PermaQuick SE. PermaQuick SE docs not recuire a separate etching step for quality adhesion. PermaQuick SE is conducive for bonding to:
-
- Dentin and Enamel using composite or amalgam
-
- Porcelain
-
- Metal
-
- Composite repair
(P LEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDE
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use _____(Per 21 CFR 801.109
OR
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-4
Robert S. Betz DDS / Dr. Susan Kummer
Division of Anesthesiology, General Hospital, Infection Control. Denta
510(k) Number: K032626