(29 days)
Pulpdent DESENSITIZER is a dental desensitizer used to control postoperative and microleakage sensitivity in teeth undergoing treatment or restoration. It can be used under veneers, inlays, crowns, onlays, amalgams and composite resins and to treat cervical or root sensitivity.
Pulpdent DESENSITIZER is a mixture of hydroxyethylmethacrylate and glutaraldehyde in water, which can be applied to all prepared cavities, to dentin and enamel, with or without the smear layer removed. Pulvdent DESENSITIZER controls dentinal fluid flow by bonding with the proteins in the tubules and thereby producing a physiologic barrier.
This document describes a dental desensitizer (PULPDENT Desensitizer) and references its safety and effectiveness. However, it does not contain any information about acceptance criteria or a study that rigorously proves the device meets specific acceptance criteria in the way that would typically be described for a medical imaging AI device or a diagnostic device.
The provided text is a summary of safety and effectiveness data for a dental material, referencing general usage and a NIH Technology Assessment Conference on "Effects and Side-Effects of Dental Restorative Materials." It focuses on the general safety of composites (a class of materials) and notes a "high benefit-to-risk ratio" based on "about 20 years" of general usage.
Therefore, I cannot provide the requested information. The document lacks:
- Specific, quantifiable acceptance criteria: There are no defined metrics (e.g., sensitivity, specificity, accuracy, precision, etc.) that the device must achieve.
- A structured study design: There's no mention of a prospective or retrospective study, a test set, ground truth establishment, or statistical analysis.
- Performance metrics: No reported device performance values are provided against any specific criteria.
- Details on ground truth, sample sizes, expert qualifications, adjudication, or MRMC studies.
The "SUMMARY OF SAFETY AND EFFECTIVENESS DATA" here refers to a general statement about the safety of dental restorative materials, not a specific study on the PULPDENT Desensitizer against predefined acceptance criteria.
§ 872.3690 Tooth shade resin material.
(a)
Identification. Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.(b)
Classification. Class II.