Identifiers
- 510(k) Number
- K962383 FDA 510(k)
- FDA Product Code
- EMA FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 872.3275 FDA 510(k)
- Regulation Number
- 872.3275 FDA 510(k)
- Advisory Committee
- Dental FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Resilute II is a radiopaque dental resin cement classified under product code EMA. It is designed for permanent cementation of dental restorations, including inlays, crowns, bridges, veneers, posts, and splints, as well as bonded amalgam techniques. The cement is formulated as a two-paste chemical-cure or dual-cure system (base and catalyst) or as a single light-cured paste, ensuring versatility in clinical applications.
Resilute II is supplied as a sterile, single-use system for dental office use. It is intended for use in non-MRI environments due to its radiopaque properties. The product is regulated under FDA 510(k) clearance (K962383) and falls under Class II with special controls. No information regarding reusable or MRI-compatible variants is provided in the specifications.
Frequently asked questions
What types of dental restorations can Pulpdent Resilute II be used to permanently cement, and how does its dual-cure system benefit the clinician?
Pulpdent Resilute II is designed for permanent cementation of a wide range of dental restorations, including inlays, crowns, bridges, veneers, posts, and splints, as well as bonded amalgam techniques. Its dual-cure system—available as a two-paste chemical-cure or light-cured paste—provides flexibility in clinical settings where light activation may not be feasible, ensuring reliable bonding regardless of curing conditions.
Is Pulpdent Resilute II safe for use in MRI environments, and if not, why?
No, Pulpdent Resilute II is not intended for use in MRI environments due to its radiopaque properties. Radiopacity is a key feature for dental applications to ensure visibility under X-rays, but it also means the material contains elements that could interfere with MRI scans, posing a risk to patients.
How is Pulpdent Resilute II supplied, and what considerations should be made regarding its sterility and single-use nature?
Pulpdent Resilute II is supplied as a sterile, single-use system specifically for dental office use. This design ensures infection control and eliminates the need for reprocessing, reducing the risk of cross-contamination between patients. Clinicians should handle it with standard aseptic techniques and discard any unused portions after opening.
What regulatory pathway does Pulpdent Resilute II follow, and what does this mean for its clinical use?
Pulpdent Resilute II follows the FDA 510(k) clearance pathway, classified under product code EMA (Dental Resin Cement) and regulated as a Class II device with special controls. This means it has undergone FDA review to demonstrate substantial equivalence to a predicate device, ensuring it meets performance standards for dental cementation while adhering to safety and effectiveness requirements for clinical use.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: PULPDENT RESILUTE II (K962383) — FDA 510 (k) | Innolitics, PULPDENT RESILUTE II (K962383) - FDA 510 (k), PULPDENT ® Corporation - Advancing Dentistry Together, Pulpdent Resilute Ii - Beudamed
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K962383 | Class II | Active |
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Manufacturer
- Manufacturer
- Pulpdent Corporation
- FDA Applicant
- Pulpdent Corp.
Sources (1)
- FDA 510(k) K962383 24 fields · synced Sep 18, 2026