(132 days)
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No
The summary describes a sealant for dental use and contains no mention of AI, ML, image processing, or data analysis that would suggest the use of such technologies.
No.
The device is used for prophylactic sealing and as an initial layer for composite restorations, which are preventive and restorative dental procedures, not therapeutic ones.
No
Explanation: The device is described as a sealant for prophylactic sealing and for use in composite restorations, which are treatment and restorative procedures, not diagnostic ones.
No
The description clearly states "Premier Sealant," which is a physical material used for sealing pits and fissures. This indicates a hardware component, not a software-only 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 "prophylactic sealing of pits and fissures" and "micro-restorative or 'initial layer' of composite restorations." This describes a device used directly on the patient's teeth for treatment and prevention.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens in vitro (outside the body) to provide information about a physiological state, health, or disease. IVDs typically involve analyzing samples like blood, urine, tissue, etc.
Therefore, Premier Sealant is a medical device used for dental procedures, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Premier Sealant, a prescription only medical device used for prophylactic sealing of pits and fissures. It may also be used for micro-restorative or "initial layer" of composite restorations.
Product codes
EBC
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 (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)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 872.3765 Pit and fissure sealant and conditioner.
(a)
Identification. A pit and fissure sealant and conditioner is a device composed of resin, such as polymethylmethacrylate, intended for use primarily in young children to seal pit and fissure depressions (faults in the enamel) in the biting surfaces of teeth to prevent cavities.(b)
Classification. Class II.
0
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 border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is an emblem featuring a stylized depiction of three human profiles facing right, layered on top of each other to create a sense of depth and unity.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 18, 2016
Premier Dental Company Products Vincent D'Alessandro Regulatory Manager Premier Dental Products Company 1710 Romano Drive Plymouth Meeting, Pennsylvania 19462
Re: K161580 Trade/Device Name: Premier Sealant Regulation Number: 21 CFR 872.3765 Regulation Name: Pit And Fissure Sealant And Conditioner Regulatory Class: Class II Product Code: EBC Dated: July 21, 2016 Received: July 21, 2016
Dear Vincent 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.
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
1
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 devicerelated adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/ReportaProblem/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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Michael J. Ryan -S
for Tina Kiang, Ph.D. Acting 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/0 description: The image shows the word "premier" in red letters inside of a red oval. The word is in all lowercase letters and has a trademark symbol to the right of the "r". The oval is thick and has rounded corners.
1710 Romano Drive, Plymouth Meeting, PA 19462 U.S.A. 888-773-6872 / 610-239-6000 www.premusa.com
Indications for Use
510(k) Number (if known): K161580
Device Name: Premier Sealant
Indications for Use: Premier Sealant, a prescription only medical device used for prophylactic sealing of pits and fissures. It may also be used for micro-restorative or "initial layer" of composite restorations.
Prescription Use X X
(Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)
Concurrence of CDRH, Office of Device Evaluation (ODE)