(119 days)
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No
The 510(k) summary describes a chemical primer for dental restorations and contains no mention of AI, ML, image processing, or data-driven performance metrics.
No
This device is a primer used to improve adhesion of dental materials, not to treat a disease or condition for therapeutic purposes.
No
The device is a silane coupling agent used for preparing ceramic materials to improve adhesion, not for diagnosing medical conditions.
No
The device description and intended use clearly describe a chemical primer used in dentistry, 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 clearly states that the device is a "silane coupling agent intended for preparation of ceramic materials... designed to improve adhesion to resin materials prior to cementation or restoration." This describes a material used in a dental procedure to prepare a restoration for bonding, which is an in vivo application (used within the body or on materials that will be placed in the body).
- Lack of IVD Characteristics: An IVD is a medical device intended for use in vitro for the examination of specimens, including blood, tissue, and urine, from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The description of this device does not involve the examination of any biological specimens.
Therefore, based on the provided text, the Premier Ceramic Primer is a dental material used in a clinical setting, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Premier Ceramic Primer is a prescription-only, one-step silane coupling agent intended for preparation of ceramic materials such as porcelain, ceramic, hybrid ceramic or composite resin and zirconia restorations designed to improve adhesion to resin materials prior to cementation or restoration. This primer does not require prior sandblasting or the use of an etchant.
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
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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
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Key Metrics
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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.
0
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the bird symbol. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 26, 2013
Premier Dental Products Company Mr. Vincent D'Alessandro . Regulatory Manager 1710 Romano Drive PLYMOUTH MEETING PA 19462-4500
Re: K131212
Trade/Device Name: Premier Ceramic Primer Regulation Number: 21 CFR 872.3200 Regulation Name: Resin Tooth Bonding Agent Regulatory Class: II Product Code: KLE Dated: May 28, 2013 Received: June 5, 2013
Dear Mr. D'Alessandro:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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. D'Alessandro
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Mary S. Runner -S
Kwame Ulmer, M.S. Acting Division Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Image /page/2/Picture/1 description: The image shows the word "premier" in bold, black letters inside of a black, rounded rectangle. The word is white, and the rectangle is black. The word "premier" is written in a sans-serif font.
1710 Romano Drive, Plymouth Meeting, PA 19462 U.S.A P: 610-239-6000 / F: 888-773-6872 www.premusa.com
Indications for Use
510(k) Number (If known): K131212
Device Name: Premier Ceramic Primer
Indications for Use: Premier Ceramic Primer is a prescription-only, one-step silane coupling agent intended for preparation of ceramic materials such as porcelain, ceramic, hybrid ceramic or composite resin and zirconia restorations designed to improve adhesion to resin materials prior to cementation or restoration. This primer does not require prior sandblasting or the use of an etchant.
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. Prescription Use ___________________________________________________________________________________________________________________________________________________________
(Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Sheena A. Green -S Sheena A. Green -5
2013.08.26 10:54:55 -04:00 -24:20 for M. Susan Runner, DDS, MA
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number. K131212
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