Pulpdent Microfilled Anterior Composite
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K945058 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 Microfilled Anterior Composite is a dental restorative material classified under Material, Tooth Shade, Resin in the FDA’s nomenclature. This composite is designed for anterior tooth restorations, providing a durable, tooth-colored filling that mimics natural dentition while maintaining aesthetic and functional integrity.
Supplied as a single-use dental restorative material, this composite is intended for use in clinical settings by dental professionals. It is regulated under FDA 510(k) clearance (K945058) with a classification of Device Class 2, and its sterility and handling are governed by standard dental practice protocols. The product is available in various tooth shade options to match patient dentition.
Frequently asked questions
What types of dental restorations is the Pulpdent Microfilled Anterior Composite specifically designed for, and why is it preferred for those areas?
The Pulpdent Microfilled Anterior Composite is specifically designed for restorations on anterior (front) teeth, such as incisors and canines. It is preferred for these areas because its microfilled composition provides a natural, translucent finish that closely mimics the appearance of natural tooth enamel, ensuring a seamless aesthetic result. This material is ideal for clinical settings where visual appeal and durability are critical for front teeth.
How is the Pulpdent Microfilled Anterior Composite supplied, and is it intended for single-use or reuse?
The Pulpdent Microfilled Anterior Composite is supplied as a single-use dental restorative material, meaning each unit is intended for one clinical application only. This aligns with standard dental practice protocols to ensure sterility and prevent cross-contamination, as it is not designed for reuse.
What tooth shade options are available for the Pulpdent Microfilled Anterior Composite, and how does this benefit patients?
The Pulpdent Microfilled Anterior Composite is available in various tooth shade options, allowing dental professionals to match the filling material to the patient’s natural dentition. This ensures a more aesthetically pleasing result, as the restoration blends seamlessly with the surrounding teeth, reducing visibility and improving overall appearance.
How is the regulatory status of this composite determined, and what does the FDA classification mean for its use?
The Pulpdent Microfilled Anterior Composite holds an FDA 510(k) clearance (K945058), which means it has been determined to be *substantially equivalent* to a legally marketed device already on the market. This classification (Device Class 2) indicates it poses moderate risk and requires compliance with specific regulatory controls, including adherence to sterility and handling protocols established for dental restorative materials. Clinicians can rely on this clearance as confirmation that the product meets FDA standards for safety and effectiveness.
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 MICROFILLED ANTERIOR COMPOSITE (K945058) — FDA 510 (k ..., PULPDENT MICROFILLED ANTERIOR COMPOSITE 510(k) K945058 - fda.report, PDF K945058 - Pulpdent Microfilled Anterior Composite, 510(k) K945058 — PULPDENT MICROFILLED ANTERIOR COMPOSITE, PULPDENT ® Corporation - Advancing Dentistry Together
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K945058 | Class II | Active |
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Manufacturer
- Manufacturer
- Pulpdent Corporation
- FDA Applicant
- Pulpdent Corp.
Sources (1)
- FDA 510(k) K945058 24 fields · synced Sep 18, 2026