Identifiers
- 510(k) Number
- K955017 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 is a dental cement classified as a dental restorative material, designed to provide a durable and biocompatible seal in root canal treatments and other restorative procedures. It is formulated to fill and stabilize treated areas, promoting long-term protection and structural integrity.
Resilute is supplied as a single-use, two-part system requiring mixing before application. It is intended for clinical use by dental professionals in sterile conditions, adhering to standard aseptic techniques. The device is classified as Class II under FDA regulations and has received 510(k) clearance (K955017). It is not sterile at the point of sale but is packaged to maintain sterility until use.
Resilute
Frequently asked questions
What types of dental procedures is Resilute designed for, and how does it function in those applications?
Resilute is specifically formulated as a dental cement to provide a durable, biocompatible seal in root canal treatments and other restorative procedures. It fills and stabilizes treated areas, helping to promote long-term protection and structural integrity of the tooth. Its two-part system requires mixing before application, allowing it to bond securely within the dental anatomy.
Is Resilute pre-sterilized, or does it require additional sterilization before use?
Resilute is not sterile at the point of sale, but it is packaged to maintain sterility until use. Clinicians must adhere to standard aseptic techniques when preparing and applying it in sterile conditions, as it is intended for clinical use by dental professionals.
How is Resilute supplied, and what should I expect when handling the packaging?
Resilute is supplied as a single-use, two-part system that requires mixing before application. The packaging is designed to preserve sterility until the moment of use, so it must remain unopened and uncontaminated until clinical preparation begins.
What regulatory pathway was followed for FDA clearance of Resilute, and what does that mean for its use?
Resilute received FDA 510(k) clearance (K955017) under the Traditional 510(k) pathway, classified as a Class II device. This means it was determined to be substantially equivalent to a legally marketed predicate device, ensuring it meets established safety and effectiveness standards for dental restorative materials. The clearance does not imply its intended clinical use but confirms regulatory compliance.
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 ® Corporation - Advancing Dentistry Together, Pulpdent Data Breach Lawsuit Investigation - claimdepot.com, PULPDENT Corporation - dentalproductsreport.com, Pulpdent: About Us
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K955017 | Class II | Active |
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Manufacturer
- Manufacturer
- Pulpdent Corporation
- FDA Applicant
- Pulpdent Corp.
Sources (1)
- FDA 510(k) K955017 24 fields · synced Sep 20, 2026