Panavia F Modification
by Kuraray America, Inc. 510(k)
Active
510(k) K002322
Overview
The Panavia F Modification is a dental adhesive resin cement, classified as a dental luting agent. It is engineered to provide strong, durable bonding between dental restorations—such as crowns, bridges, and inlays—and tooth structures, ensuring long-term stability in restorative dentistry.
Supplied as a two-part system, this cement requires mixing before use and is intended for single-use applications. It is regulated under FDA 510(k) clearance (K002322) as a Class II dental product (product code EMA) and follows the traditional 510(k) review pathway. Storage conditions are not specified but typically involve protection from moisture and extreme temperatures to preserve efficacy.
Panavia F Modification
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK002322 | Date18 Sep 2000 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- Full name
- Modification to Panavia F
- 510(k) Number
- FDA Product Code
- EMA
- Device Class
- Class II
- Regulation
- 21 CFR Part 872.3275
- Advisory Committee
- Dental
- FDA Decision
- SESE Substantially Equivalent
Other devices from Kuraray America, Inc.
Questions
What is the Panavia F Modification used for?
The Panavia F Modification is a dental adhesive resin cement designed specifically as a luting agent. It bonds dental restorations—such as crowns, bridges, and inlays—to tooth structures, ensuring long-term stability in restorative dentistry. Its primary purpose is to create a strong, durable connection between the restoration and the natural tooth, reducing the risk of loosening or failure over time.
How is the Panavia F Modification supplied and prepared for use?
This cement is supplied as a two-part system, meaning it consists of separate components that must be mixed together before application. The manufacturer provides the necessary tools or instructions for proper mixing, as this step is critical to achieving optimal bonding strength. It is intended for single-use only, so each application requires a fresh mixture.
Is the Panavia F Modification sterile, and how should it be stored?
The device data does not specify whether the Panavia F Modification is sterile as supplied. However, like most dental adhesives, it should be stored in a way that protects it from moisture and extreme temperatures to preserve its efficacy. Always follow the manufacturer’s guidelines for storage, and ensure the workspace is clean and dry before use to avoid contamination.
Can the Panavia F Modification be reused after initial application?
No, the Panavia F Modification is explicitly intended for single-use applications. Once mixed and applied, the cement should not be reused. Reusing mixed adhesive could compromise its bonding properties and increase the risk of failure or infection, as residual material may harbor bacteria or degrade over time.
What regulatory pathway does the Panavia F Modification follow?
The Panavia F Modification is regulated under the FDA’s 510(k) clearance pathway, classified as a Class II dental product under product code EMA. It was determined to be substantially equivalent to a predicate device and follows the traditional 510(k) review process. This means its safety and effectiveness were evaluated against a previously approved dental luting agent to ensure compliance with regulatory standards.