Conquest Direct Filling Composite (DFC)
510(k) K904724
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK904724 | Date7 Dec 1990 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- KLE
- Device Class
- Class II
- Regulation
- 21 CFR Part 872.3200
- Advisory Committee
- Dental
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Conquest Direct Filling Composite (DFC) is a dental resin-based material classified as an Agent, Tooth Bonding under the FDA’s nomenclature. It is designed for direct restoration of dental cavities, providing durable filling material that bonds to tooth structure to restore function and aesthetics. The composite is formulated to harden upon exposure to light, enabling precise placement and shaping during restorative procedures. Its primary use is in posterior and anterior teeth to fill defects and prevent further decay progression.
Supplied as a single-use, light-cured dental composite, the Conquest DFC is intended for use in clinical dental settings by trained professionals. It is packaged in sterile, individual units for immediate application, ensuring contamination control. The device is regulated under FDA’s 510(k) clearance (K904724) as a Class II medical device, adhering to dental restoration standards. No MRI safety or reusable specifications are noted; storage requires protection from moisture and light as per manufacturer guidelines.
Other devices from Jeneric/Pentron, Inc.
Questions
AI-generated answers, 1 Oct 2026
What is the Conquest Direct Filling Composite (DFC) used for?
The Conquest DFC is a resin-based dental composite designed specifically for direct restoration of dental cavities. It bonds to tooth structure to restore function and aesthetics, making it suitable for filling defects in both posterior (back) and anterior (front) teeth. This helps prevent further decay progression and provides a durable, natural-looking restoration.
How is the Conquest DFC supplied and what does this mean for clinical use?
The Conquest DFC is supplied as a single-use, sterile, individual unit. This packaging ensures contamination control and immediate application in clinical settings, eliminating the need for sterilization or reprocessing between uses. It is intended exclusively for trained dental professionals to ensure proper handling and placement.
Is the Conquest DFC reusable or single-use, and why does this matter?
The Conquest DFC is designed for single-use only. This is important because single-use materials reduce the risk of cross-contamination between patients, ensuring patient safety and compliance with infection control protocols. Reusing dental composites can introduce bacteria or other contaminants, compromising sterility and potentially leading to infections.
What storage conditions are required for the Conquest DFC?
The Conquest DFC must be stored protected from moisture and light. Exposure to moisture can degrade the material’s properties, while light—particularly ultraviolet light—can prematurely harden the composite or alter its chemical composition. Proper storage ensures the material remains effective and ready for use when needed in clinical procedures.
What regulatory pathway does the Conquest DFC follow, and what does this indicate?
The Conquest DFC follows the FDA’s 510(k) clearance pathway, specifically classified as a Class II medical device under the category of Agent, Tooth Bonding. This classification indicates that the device has been determined to be substantially equivalent to a legally marketed predicate device, meaning it meets established safety and effectiveness standards for dental restorations. The clearance number is K904724.