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Pulpdent Micro-Hybrid Composite

FDA 510(k)

Class II (US FDA 510(k))

510(k) K090391

by Pulpdent Corporation

Identifiers

510(k) Number
K090391 FDA 510(k)
FDA Product Code
EBF FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 872.3690 FDA 510(k)
Regulation Number
872.3690 FDA 510(k)
Advisory Committee
Dental FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Pulpdent Micro-Hybrid Composite is a dental restorative material classified as a resin-based composite (product code EBF). It is designed for use in direct tooth restorations, providing durable, tooth-colored fillings that restore function and aesthetics to damaged or decayed teeth. This material combines micro-hybrid filler particles with a resin matrix to achieve balanced mechanical properties and esthetic results.

Supplied as a single-use, non-sterile dental composite, this material is intended for use in clinical settings by dental professionals. It requires mixing and placement by the operator, with curing performed using a visible light source. The device is regulated under FDA 510(k) clearance (K090391) as substantially equivalent to predicate products, adhering to Class II special controls for dental restorative materials. Storage conditions are not specified in the regulatory data.

Frequently asked questions

What types of dental restorations is the Pulpdent Micro-Hybrid Composite specifically designed for?

The Pulpdent Micro-Hybrid Composite is designed for direct tooth restorations, meaning it is used to fill cavities or repair damaged areas in teeth. Its micro-hybrid filler particles and resin matrix provide a durable, tooth-colored filling that restores both function and aesthetics, making it suitable for restoring decayed or damaged teeth in clinical settings.

Is the Pulpdent Micro-Hybrid Composite single-use or reusable, and how should it be handled?

The Pulpdent Micro-Hybrid Composite is supplied as a single-use material, meaning each application requires a new unit. Since it is non-sterile, it must be handled in a clinical setting by dental professionals who will mix and place the material before curing it with a visible light source.

What are the key differences between this composite and other dental filling materials?

This composite combines micro-hybrid filler particles with a resin matrix to balance mechanical strength and aesthetic appeal, making it ideal for durable, tooth-colored restorations. Unlike some other composites, it is explicitly designed for direct tooth restorations, ensuring it adheres well to the tooth structure while providing longevity and a natural appearance.

How is the regulatory status of this composite determined, and what does that mean for its use?

The Pulpdent Micro-Hybrid Composite holds FDA 510(k) clearance (K090391) under the product code EBF, meaning it has been deemed substantially equivalent to predicate dental restorative materials. This classification places it under Class II special controls, ensuring it meets safety and effectiveness standards for dental use in clinical settings by authorized professionals.

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 MICRO-HYBRID COMPOSITE (K090391) — FDA 510(k) | Innolitics, PDF P'ULPDENT CORPORATION Notification b (Pulpdlent Micro-Hybrid Composite ..., K090391 - PULPDENT MICRO-HYBRID COMPOSITE | FDA 510 (k)

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Pulpdent Corporation

Sources (1)

  • FDA 510(k) K090391 24 fields · synced Sep 18, 2026