LUTE VLC - Lute Vlc
510(k) K011309
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK011309 | Date22 Jun 2001 | 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- Withdrawn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
- Models / Variants
- Lute Vlc
- Device Class
- Class II
- Regulation
- 21 CFR Part 872.3690
- Advisory Committee
- Dental
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
The LUTE VLC; CORE VLC is a Tooth Shade Resin Material, classified under FDA regulation 872.3690. This device is composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) and is designed to restore carious lesions or structural defects in teeth. It falls under the broader category of dental restorative materials, intended for permanent or semi-permanent use in oral reconstruction.
This device is supplied as a dual-component system for dental luting and core build-up applications, requiring mixing and polymerization via visible light curing (VLC). It is intended for single-use per manufacturer specifications and must be handled in a sterile or aseptic environment to prevent contamination. The product is regulated under FDA 510(k) clearance (K011309) with a traditional review process, classified as a Class II device under the Dental advisory committee. Storage conditions and reusability are not specified in the available data.
Other devices from First Scientific Limited
Questions
AI-generated answers, 19 Sep 2026
What types of dental issues is the LUTE VLC; CORE VLC designed to address in a clinical setting?
The LUTE VLC; CORE VLC is specifically formulated as a tooth shade resin material to restore carious lesions (cavities) or structural defects in teeth. It is intended for permanent or semi-permanent use in oral reconstruction, meaning it can be used to fill or rebuild damaged areas of a tooth to restore function and appearance.
How is the LUTE VLC; CORE VLC supplied and what preparation is required before use?
The LUTE VLC; CORE VLC comes as a dual-component system, meaning it requires mixing of two parts before application. After mixing, it must be polymerized using visible light curing (VLC) to harden. Since it is designed for single-use, each application should use a fresh mixture to ensure sterility and prevent contamination.
Is the LUTE VLC; CORE VLC intended for reuse, and what precautions should be taken during handling?
The manufacturer specifies that the LUTE VLC; CORE VLC is intended for single-use only. To maintain sterility and prevent contamination, it must be handled in a sterile or aseptic environment, as improper handling could compromise its integrity and safety for dental procedures.
What key material components make up the LUTE VLC; CORE VLC, and how does this relate to its use?
The LUTE VLC; CORE VLC contains bisphenol-A glycidyl methacrylate (Bis-GMA), a common resin material in dental composites. This composition allows it to bond well to tooth structures, providing durability and aesthetic matching to natural tooth shade, making it suitable for restorative and core build-up applications in dental work.
What regulatory pathway was followed for the FDA clearance of the LUTE VLC; CORE VLC, and what does this imply about its classification?
The LUTE VLC; CORE VLC underwent a traditional review process through the FDA’s 510(k) clearance pathway (K011309) and is classified as a Class II device under the Dental advisory committee. This classification indicates it poses moderate risk and requires special controls to ensure its safety and effectiveness for dental luting and core build-up applications.