PULPDENT RESILUTE II
Device Facts
| Record ID | K962383 |
|---|---|
| Device Name | PULPDENT RESILUTE II |
| Applicant | Pulpdent Corp. |
| Product Code | EMA · Dental |
| Decision Date | Sep 3, 1996 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 872.3275 |
| Device Class | Class 2 |
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.
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.
Indications for Use
Indicated for permanent cementation of dental inlays, crowns, bridges, veneers, posts, periodontal splints, and bonded amalgam techniques in patients requiring dental restoration.
Regulatory Classification
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
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- K040236 — PULPDENT VLC RESIN CEMENT · Pulpdent Corporation · Apr 20, 2004
- K073173 — SELF-ADHESIVE RESIN CEMENT · Dentsply Interntional · Jan 23, 2008
- K142625 — PANAVIA SA Cement Plus Automix; (Universal(A2), White, Translucent); Value Pack (Universal(A2), Translucent); Automix Trial (Universal(A2), White, Translucent); Mixing tip; Endo tip (SS) · Kuraray Noritake Dental, Inc. · Jan 27, 2015
