Pulpdent Dual Cure Unfilled Bonding Resin
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K945112 FDA 510(k)
- FDA Product Code
- KLE FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 872.3200 FDA 510(k)
- Regulation Number
- 872.3200 FDA 510(k)
- Advisory Committee
- Dental FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
This device is classified as an Agent, Tooth Bonding, Resin under the FDA nomenclature. It is a dual-cure bonding resin designed to bond to tooth structure, providing improved retention for dental restorations such as fillings. The resin is intended for use as a cavity liner to enhance adhesion between the tooth and restoration materials.
The Pulpdent Dual Cure Unfilled Bonding Resin is supplied as a single-use dental adhesive system and requires no sterilization. It is intended for use in dental settings and has been granted FDA 510(k) clearance under the classification KLE (Agent, Tooth Bonding, Resin) with regulation number 872.3200. The device is classified as a Class II medical device and is regulated under the Dental advisory committee.
Frequently asked questions
What is the Pulpdent Dual Cure Unfilled Bonding Resin used for in dental procedures?
The Pulpdent Dual Cure Unfilled Bonding Resin is designed to bond to tooth structure, serving as a cavity liner to improve adhesion between the tooth and dental restoration materials like fillings. This enhances retention and stability of the restoration.
Is the Pulpdent Dual Cure Unfilled Bonding Resin intended for reuse or is it single-use?
This device is explicitly supplied as a single-use dental adhesive system, meaning each application requires a new unit. No sterilization is required, as it is not meant to be reused.
How is the regulatory status of this device determined, and which committee oversees it?
The Pulpdent Dual Cure Unfilled Bonding Resin has received FDA 510(k) clearance under the classification *Agent, Tooth Bonding, Resin* (product code KLE) and is regulated under the Dental Advisory Committee (DE). It is classified as a Class II medical device, with the clearance determined through a traditional review process.
Does this bonding resin require any special storage conditions, and is it sterile?
The Pulpdent Dual Cure Unfilled Bonding Resin is supplied as a single-use dental adhesive system, but the data does not specify any special storage conditions or sterility claims. It is intended for use in dental settings without sterilization, as it is not reusable.
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: DenTASTIC® All Purpose - PULPDENT, PULPDENT DUAL CURE UNFILLED BONDING RESIN (K945112) — FDA 510(k ..., PULPDENT DUAL CURE UNFILLED BONDING RESIN 510(k)… - FDA.report, PULPDENT DUAL CURE UNFILLED BONDING RESIN 510(k)… - FDA.report
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K945112 | Class II | Active |
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Manufacturer
- Manufacturer
- Pulpdent Corporation
- FDA Applicant
- Pulpdent Corp.
Sources (1)
- FDA 510(k) K945112 24 fields · synced Sep 18, 2026