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Pulpdent Hard Dental Posterior Filling Material

FDA 510(k)

Class II (US FDA 510(k))

510(k) K945018

by Pulpdent Corporation

Identifiers

510(k) Number
K945018 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)

This device is a Hard Dental Posterior Filling Material, classified under product code EBF. It is designed for restoring posterior teeth by filling cavities and restoring occlusal function, providing durable dental restoration in permanent teeth.

The material is supplied as a dental filling substance and is intended for use in clinical dental settings. It has received FDA 510(k) clearance under K-number K945018, classified as substantially equivalent to a predicate device. No specific sterility or single-use/reusable designation is stated in the data.

Frequently asked questions

What types of teeth is this filling material specifically designed to restore, and how does it differ from materials used for front teeth?

This filling material is specifically designed for posterior teeth—the molars and premolars at the back of the mouth. Unlike materials for front teeth, which prioritize aesthetics, this product focuses on durability and occlusal function, meaning it’s built to withstand the heavy chewing forces in back teeth. It’s not intended for anterior (front) teeth, where appearance and smoothness are critical.

How is this filling material supplied, and what should clinicians expect when handling it in a clinical setting?

The material is supplied as a dental filling substance—likely in a pre-packaged, clinician-applied format (e.g., capsules, syringes, or tubes) for direct placement in cavities. Since no explicit sterility or single-use designation is provided, clinicians should follow standard dental protocols for handling restorative materials, including proper mixing (if applicable) and application techniques. Always refer to the manufacturer’s instructions for specific handling.

Is this filling material reusable, or is it intended for single-use in a patient? How does that affect its storage requirements?

The data does not specify whether the material is reusable or single-use. However, as a hard dental filling substance, it is typically designed for one-time use per patient to ensure sterility and prevent cross-contamination. Storage should follow the manufacturer’s guidelines (e.g., sealed, dry environment, protected from light), but clinicians should assume it’s non-reusable unless confirmed otherwise in accompanying documentation.

What regulatory pathway was followed for this device’s approval, and what does that mean for clinicians using it?

This material received FDA 510(k) clearance under K-number K945018, classified as substantially equivalent (SESE) to a predicate device. This means the FDA determined it has the same intended use and technological characteristics as an existing approved product, ensuring it meets safety and effectiveness standards. Clinicians can rely on this approval as evidence of regulatory scrutiny, though they should always follow the manufacturer’s instructions for proper 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 Hard Dental Posterior Filling Material, Pulpdent | Advancing Dentistry Together, Pulpdent Hard Dental Posterior Filling Material - allmed.wiki, ACTIVA™ Presto™ - PULPDENT, Product Catalog - Pulpdent Corporation - PDF Catalogs | Technical ...

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) K945018 24 fields · synced Sep 18, 2026