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Pulpdent Cervical Restorative

FDA 510(k)

Class II (US FDA 510(k))

510(k) K945113

by Pulpdent Corporation

Identifiers

510(k) Number
K945113 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 Cervical Restorative is a dental restorative material designed for repairing and restoring the occlusal surfaces of posterior teeth, particularly in cervical areas affected by decay or wear. Classified under product code EBF, it is intended for use in restorative dentistry to provide durable, tooth-colored fillings that blend with natural dentition.

This device is supplied as a reusable dental material and requires proper handling and storage as per manufacturer guidelines. It is intended for use in clinical dental settings and has received FDA 510(k) clearance under the Traditional pathway, with a clearance date of December 14, 1994. The product is regulated under dental device classification and adheres to standard dental restorative protocols.

Frequently asked questions

What specific areas of teeth does the Pulpdent Cervical Restorative target for restoration, and why is this material chosen for those areas?

The Pulpdent Cervical Restorative is specifically designed for repairing and restoring the occlusal surfaces of posterior teeth, particularly in the cervical regions where decay or wear is common. This material is chosen for these areas because it provides durable, tooth-colored fillings that blend seamlessly with natural dentition, ensuring both functionality and aesthetics in high-stress regions of the mouth.

How is the Pulpdent Cervical Restorative supplied, and what kind of handling and storage precautions should be taken?

The Pulpdent Cervical Restorative is supplied as a reusable dental material, meaning it is intended for multiple uses in clinical settings with proper handling. While the exact storage instructions are detailed in the manufacturer’s guidelines, typical dental restorative materials require protection from moisture, extreme temperatures, and contamination to maintain integrity. Always follow Pulpdent Corporation’s instructions to ensure optimal performance and longevity.

Is this material intended for single-use or can it be reused? How does this affect its clinical application?

The Pulpdent Cervical Restorative is explicitly described as a *reusable* dental material, meaning it is designed for repeated clinical use under proper conditions. This allows for cost-effective application in dental practices, as it can be used across multiple patients with appropriate sterilization or cleaning protocols between uses, provided it adheres to standard dental restorative handling guidelines.

What regulatory pathway was followed for FDA clearance of this product, and what does that mean for its use in clinical settings?

The Pulpdent Cervical Restorative received FDA clearance through the Traditional 510(k) pathway, specifically determined to be *substantially equivalent* to a legally marketed predicate device. This means the FDA reviewed it against existing dental restorative materials and confirmed it meets the same performance standards for safety and effectiveness. Clinically, this clearance indicates the product adheres to established dental restorative protocols and is suitable for use in standard dental practices.

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 CERVICAL RESTORATIVE (K945113) — FDA 510(k) | Innolitics, Pulpdent Cervical Restorative - allmed.wiki, Pulpdent: About Us, Pulpdent Cervical Restorative 510 (k) FDA Premarket Notification ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Pulpdent Corporation
FDA Applicant
Pulpdent Corp.

Sources (1)

  • FDA 510(k) K945113 24 fields · synced Sep 18, 2026