← Product Code [EMA](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EMA) · K962383 # PULPDENT RESILUTE II (K962383) _Pulpdent Corp. · EMA · Sep 3, 1996 · Dental · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EMA/K962383 ## Device Facts - **Applicant:** Pulpdent Corp. - **Product Code:** [EMA](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EMA.md) - **Decision Date:** Sep 3, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 872.3275 - **Device Class:** Class 2 - **Review Panel:** Dental ## Indications for Use Pulpdent ResiLute II™ is a radiopaque, resin cement for the permanent cementation of dental inlays, crowns, bridges, veneers, posts, periodontal splints and for bonded amalgam techniques. ## Device Story Pulpdent ResiLute II™ is a radiopaque resin cement used by dentists for permanent cementation of various dental restorations (inlays, crowns, bridges, veneers, posts, splints) and bonded amalgam techniques. Supplied as a two-paste chemical-cure or dual-cure system (base and catalyst) or a single light-cured paste, with or without fluoride. Applied by clinicians in dental offices. Provides low film thickness and bonds to enamel, dentin, metals, and ceramics. Facilitates secure attachment of restorative materials to tooth structure, improving clinical outcomes for dental repairs. ## Clinical Evidence No clinical data. Safety and effectiveness supported by reference to NIH Technology Assessment Conference findings on dental restorative materials, citing 20 years of general usage and billions of procedures without evidence of risk. ## Technological Characteristics Radiopaque resin cement; two-paste (base/catalyst) chemical or dual-cure system or single light-cured paste; contains fluoride options. Conforms to ADA Specification No. 27 for Direct Filling Resins. Bonds to enamel, dentin, metals, and ceramics. ## Regulatory 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. 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. ## Predicate Devices - 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 ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0} 510 k Pre-Market Notification SEP 3 1996 K962383 Pulpdent ResiLute II™ 52 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 FAX: (617) 926-6262 DEVICE NAME: Pulpdent ResiLute II™ 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 II™ 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 II™ conforms to ADA Specification No. 27 for Direct Filling Resins (see EXHIBIT 7); when a specification is adopted for resin cements, Pulpdent ResiLute II™ will conform to it. COMPARISON WITH PREDICATE PRODUCTS: Pulpdent ResiLute II™ 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. --- **Source:** [https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EMA/K962383](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EMA/K962383) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com