Pulpdent Hybrid Anterior Composite
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K945057 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 Hybrid Anterior Composite is a dental restorative material classified as a composite resin for anterior tooth restoration. It is designed to restore and repair the front teeth by providing durable, aesthetically pleasing fillings that mimic natural tooth enamel in color and translucency.
This composite is supplied as a single-use dental filling material and is intended for use in clinical dental settings by licensed professionals. It requires proper handling, storage, and application according to standard dental procedures. The device holds an FDA 510(k) clearance under the product code EBF, with a decision date of December 14, 1994, and is classified under the Dental advisory committee.
Frequently asked questions
What types of teeth is this composite specifically designed to restore, and how does it compare to natural enamel in appearance?
The Pulpdent Hybrid Anterior Composite is designed exclusively for restoring and repairing the front (anterior) teeth. Its formulation is engineered to closely mimic natural tooth enamel in both color and translucency, providing a durable and aesthetically pleasing result that blends seamlessly with the surrounding teeth.
Is this composite intended for single-use only, and if so, why is that important for clinical settings?
Yes, the Pulpdent Hybrid Anterior Composite is supplied as a single-use dental filling material. This ensures sterility and reduces the risk of cross-contamination between patients, which is critical in clinical settings where infection control is paramount. Single-use also simplifies inventory management and disposal protocols.
How should this composite be stored, and are there any specific handling instructions to maintain its integrity?
While the exact storage instructions aren’t detailed in the provided data, dental composites like this typically require protection from moisture, extreme temperatures, and direct light. The manufacturer’s guidelines (not listed here) would specify storage conditions, but generally, it should be kept in a cool, dry place within the manufacturer’s recommended shelf life to preserve its properties for optimal clinical performance.
What does the FDA clearance under product code EBF (Dental advisory committee) mean for clinicians using this product?
The FDA 510(k) clearance under product code EBF (for dental restorative materials) indicates that the Pulpdent Hybrid Anterior Composite has been reviewed and deemed substantially equivalent to a legally marketed predicate device. This means it meets FDA safety and effectiveness standards for anterior tooth restorations, allowing licensed dental professionals to use it with confidence in clinical settings. The clearance date (December 14, 1994) reflects when this determination was made.
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 HYBRID ANTERIOR COMPOSITE (K945057) — FDA 510 (k) | Innolitics, Pulpdent Hybrid Anterior Composite - Beudamed, PDF K945057 - Pulpdent Hybrid Anterior Composite, PULPDENT ® Corporation - Advancing Dentistry Together, FDA 510(k) Applications Submitted by Pulpdent Corporation
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K945057 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Pulpdent Corporation
- FDA Applicant
- Pulpdent Corp.
Sources (1)
- FDA 510(k) K945057 24 fields · synced Sep 18, 2026