(75 days)
Pulpdent ResiLute IITM is a radiopaque, resin cement for the permanent cementation of dental inlays, crowns, bridges, veneers, posts, periodontal splints and for bonded amalgam techniques.
Pulpdent ResiLute IITM is a radiopaque, resin cement... It is supplied as a chemical-cure or dual-cure two-paste system (base and catalyst), with and without fluoride, that mixes easily, and as a single light-cured paste, also with and without fluoride. Pulpdent ResiLute II™ has a very low film thickness and bonds to enamel, dentin, metals and ceramic.
The provided document is a 510(k) summary for a dental resin cement, Pulpdent ResiLute II™. It does not contain information about acceptance criteria or a study proving device performance in the context of an AI/ML medical device.
Therefore, I cannot extract the requested information as it is not present in the provided text.
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3 1996 성금융
Pulpdent ResiLute II™
EXHIBIT 8
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 (617) 926-6262 FAX:
Pulpdent ResiLute II™ DEVICE NAME:
PREDICATE DEVICE:
Pulpdent HardCore Pulpdent Resin Cement Pulpdent ResiLute Septodent RESIMENT Bisco All Bond C & B Luting Cement Cosmedent Insure Kerr Porcelite / Porcelite Dual Cure Bisco Choice Porcelain Veneer System
DESCRIPTION AND INTENDED USE: Pulpdent ResiLute IITM is a radiopaque, resin cement for the permanent cementation of dental inlays, crowns, bridges, veneers, posts, periodontal splints and for bonded amalgam techniques. It is supplied as a chemical-cure or dual-cure two-paste system (base and catalyst), with and without fluoride, that mixes easily, and as a single light-cured paste, also with and without fluoride. Pulpdent ResiLute II™ has a very low film thickness and bonds to enamel, dentin, metals and ceramic. Pulpdent ResiLute INM conforms to ADA Specification No. 27 for Direct Filling Resins (see EXHIBIT 7); when a specification is adopted for resin cements, Pulpdent ResiLute IITM will conform to it.
COMPARISON WITH PREDICATE PRODUCTS: Pulpdent ResiLute IITM is substantially equivalent in composition and intended use to the above mentioned predicate 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...both composites and glass ionomers 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 papers from the conference.
§ 872.3275 Dental cement.
(a)
Zinc oxide-eugenol —(1)Identification. Zinc oxide-eugenol is a device composed of zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.(2)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 872.9.(b)
Dental cement other than zinc oxide-eugenol —(1)Identification. Dental cement other than zinc oxide-eugenol is a device composed of various materials other than zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.(2)
Classification. Class II.