Occlusin Light Cured Visible Radiopaque Composite
510(k) K844326
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK844326 | Date3 Dec 1984 | 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- Withdrawn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
- EBF
- Device Class
- Class II
- Regulation
- 21 CFR Part 872.3690
- Advisory Committee
- Dental
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Occlusin Light Cured Visible Radiopaque Composite is a dental composite material designed for restorative applications in dentistry. Classified under product code EBF, it is a radiopaque, light-activated composite intended for use in dental fillings and restorations, providing visibility under X-ray imaging for diagnostic purposes.
This composite is supplied as a single-use dental material and requires light curing to harden in place. It is regulated under FDA 510(k) clearance (K844326) and falls under the Dental advisory committee classification. The device is intended for use in clinical settings by dental professionals, adhering to standard dental restoration protocols. No additional sterility or reusable specifications are noted in the regulatory data.
Other devices from Coe Laboratories, Inc.
Questions
AI-generated answers, 1 Oct 2026
What is the Occlusin Light-Cured Visible Radiopaque Composite used for?
This composite is specifically designed for dental restorative applications, such as fillings and repairs. Its radiopaque properties allow visibility under X-ray imaging, which is critical for diagnosing and monitoring the placement and integrity of dental restorations over time. The light-curing feature ensures proper hardening in the mouth, adhering to standard dental restoration protocols.
How is the Occlusin Light-Cured Visible Radiopaque Composite supplied?
The Occlusin Light-Cured Visible Radiopaque Composite is supplied as a single-use dental material. This means each application requires a new unit, ensuring sterility and reducing the risk of cross-contamination in clinical settings. The material is intended for professional use only by dental practitioners.
Is sterility a concern with this composite?
No additional sterility specifications are noted for this composite beyond its single-use design. Since it is intended for one-time clinical use, the manufacturer ensures it meets regulatory standards for dental materials without requiring further sterilization procedures by the user. Always follow manufacturer guidelines for handling and application.
Can this composite be reused?
No, this composite is explicitly designed for single-use only. Reusing dental composites can compromise patient safety by introducing contamination risks or altering the material’s properties. The radiopaque and light-cured features are optimized for one application, ensuring reliable performance and diagnostic visibility.
What regulatory approval does the Occlusin Light-Cured Visible Radiopaque Composite hold?
The Occlusin Light-Cured Visible Radiopaque Composite holds FDA 510(k) clearance under the classification of Dental (product code EBF). This clearance indicates that the device has been deemed substantially equivalent to a legally marketed predicate device, meeting regulatory standards for safety and effectiveness in dental restorative applications.