(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.
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X963652
OCT 11 1996
EXHIBIT 7
RESPONSE TO SMDA OF 1990
SUMMARY OF SAFETY AND EFFECTIVENESS DATA
Kenneth J. Berk 80 Oakland Street PO Box 780 Watertown. MA 02272-0780 USA.
TELEPHONE: (617) 926-6666 FAX: (617) 926-6262 .
PULPDENT Desensitizer DEVICE NAME:
PREDICATE DEVICES: American Dental Products Wetting Agent and Desensitizer Health-Dent Hema-Glu Miles Inc. Gluma
DESCRIPTION AND INTENDED USE: 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.
COMPARISON WITH PREDICATE PRODUCTS: Pulpdent DESENSITIZER is substantially equivalent in composition and intended use as the products. Please see Exhibit 5 for the entire comparison.
SAFETY AND EFFECTIVENESS: According to the NIH Technology Assessment Conference on Effects and Side-Effects of Dental Restorative Materials, "General usage of these materials over about 20 years indicates a high benefit-to-risk ratio... composites ... are relatively trouble free. There is no evidence of short or long term risk ... there is no suspicion of any problems after literally billions of procedures in the United States." Please see Exhibit 6 for the complete journal articles.
§ 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.