(57 days)
For use in repairing, adding to, or otherwise modifying the surface of resins . Especially useful for enhancing co-polymentzation between an old and a new composite resin when the former requires refreshing or repair in clinical life. May also be used as the primer of indirect, resin-based restorations to enhance the bond of these with resin-based luting materials. This agent is also useful for bond of highly cross-inked denture teeth, acrylic or composite, to denture base resins, This material will improve the union between resin surfaces in a myriad of situations, both intra- and exta-orally.
A light-cured, resin-based primer that is used to enhance the bond of old to new resin-based materials. The material is indicated for use on the intaglio of indirect composite restorations. It can be used to refresh the worn but otherwise intact surfaces of composite resin restorations.
The provided text is a 510(k) summary for a dental resin primer, not an AI/ML device. Therefore, it does not contain information about studies proving the device meets acceptance criteria in the context of AI/ML, nor does it have details like sample sizes for test/training sets, expert qualifications, or MRMC studies.
The document describes a dental product "Comp. E" (a resin primer) and its intended use, along with a regulatory equivalence comparison to "Special Bond and Special Bond II". The FDA's letter states that the device is substantially equivalent to legally marketed predicate devices. This typically means that the device has similar technological characteristics and is intended for the same use as a predicate device that was on the market prior to May 28, 1976, or has been reclassified.
Without the specific type of device being an AI/ML product, the questions related to AI/ML acceptance criteria, study methodologies for AI/ML, and expert adjudication cannot be answered from the provided text.
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510(k) SUMMARY
| Submitter: | Parkell, Inc.155 Schmitt Blvd.Box 376Farmingdale, NY 11735TEL: 631-249-1134FAX: 631-249-1242 |
|---|---|
| Contact: | Nelson J. Gendusa, DDSDirector of ResearchParkell155 Schmitt Blvd.Box 376Farmingdale, NY 11735 |
| Submission Date: | 15 April 2003 |
| Trade Name: | Currently Not Available |
| Common Name: | Resin Primer |
| Classification Name: | Material, Tooth Shade, Resin |
| Equivalence: | Special Bond and Special Bond II |
| Description/Intended Use: | A light-cured, resin-based primer that is used to enhancethe bond of old to new resin-based materials. Thematerial is indicated for use on the intaglio of indirectcomposite restorations. It can be used to refresh theworn but otherwise intact surfaces of composite resinrestorations. |
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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 consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" written around it. Inside the circle is a stylized symbol that resembles three overlapping human figures or abstract shapes. The symbol is composed of curved lines and is positioned in the center of the circle.
Public Health Service
SEP - 9 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Nelson J. Gendusa, DDS Director of Research Parkell, Incorporated 155 Schmitt Boulevard, Box 376 Farmingdale, New York 11735
Re: K032179
Trade/Device Name: Comp.E Regulation Number: 21 CFR 872.3200 Regulation Name: Resin Tooth Bonding Agent Regulatory Class: II Product Codes: KLE and EBI Dated: July 09, 2003 Received: July 14, 2003
Dear Dr. Gendusa:
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 - Nelson J. Gendusa, DDS
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 (OS) 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. 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) you may obtain. 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.
Susan Runner
Susan Runner, DDS, MA
Susan Runner, DDS, MA Interim 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 1
510(k) Number (if known):_
Device Name: _Comp. E
Indications for Use: For use in repairing, adding to, or otherwise modifying the surface of resins . Especially useful for enhancing co-polymentzation between an old and a new composite resin when the former requires refreshing or repair in clinical life. May also be used as the primer of indirect, resin-based restorations to enhance the bond of these with resin-based luting materials. This agent is also useful for bond of highly cross-inked denture teeth, acrylic or composite, to denture base resins, This material will improve the union between resin surfaces in a myriad of situations, both intra- and exta-orally.
Kai Mully for MSR
(Division Sign-Off)
Division of Anesthesiology, General Hospital,
Infection Control, Dental Devices
510(k) Number: K 032179
§ 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.