(87 days)
The 3M™ Clinpro™ Sealant can be used as a pit and fissure sealant. It is intended to be used on posterior teeth and is not permanent.
Pit and fissure sealant .
3M™ Clinpro™ Sealant is a single part, light curing, pit and fissure sealant. This device, as well as the predicate device, are based on methacrylate resin chemistry.
The provided text describes the 3M™ Clinpro™ Sealant device and its regulatory submission, but it does not contain a study that outlines acceptance criteria and its performance against those criteria in the context of device evaluation.
The document discusses the device's substantial equivalence to a predicate device based on bench tests and compliance with an ISO standard. However, these are not presented as a formal study with detailed acceptance criteria and reported device performance in the format requested.
Therefore, I cannot fulfill the request for a table of acceptance criteria and reported device performance, nor can I provide information on sample size, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, type of ground truth, or training set details as these are not present in the provided text.
The closest information available is:
Acceptance Criteria (Implied / Stated in document):
- Similar technological characteristics to the predicate device (3M™ Concise™ Light Cure White Sealant), specifically based on methacrylate resin chemistry.
- Performance similar or better than the predicate device as validated by "bench tests".
- Compliance with ISO 6874-1988 "Dental resin-based pit and fissure sealants."
"Reported Device Performance" (Based on Bench Tests Mentioned):
The document states that the following bench tests were conducted, implying the device performed acceptably in these:
- Shear Bond Strength
- Ambient Light Sensitivity
- Cure Time
- Depth of Cure
- Uncured Film Thickness
Study Information (Not provided in the document in detail):
As stated, no detailed study is presented to describe the methodology, sample sizes, expert involvement, or specific performance metrics against defined acceptance criteria. The document only lists the types of bench tests performed and the ISO standard met.
§ 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.