Fiber Mesh
by Fiber Mesh, Inc. 510(k)
Active
510(k) K855005
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK855005 | Date30 Jan 1986 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- DZE
- Device Class
- Class II
- Regulation
- 21 CFR Part 872.3640
- Advisory Committee
- Dental
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Fiber Mesh is a micro-reinforcement fiber designed to strengthen and reinforce cementitious materials, such as parge coats. Classified under the product code DZE in the Dental category, it functions by embedding within the matrix to enhance structural integrity, durability, and resistance to stress and impact. Its primary role is to provide mechanical reinforcement, improving the material’s ability to withstand mechanical forces and reducing cracking under load.
This device is supplied as a dry fiber reinforcement material and is intended for integration into cement-based coatings like parge coats. It is not sterile and is classified as a reusable material for construction applications rather than a medical device in clinical use. The product is authorized under an FDA 510(k) clearance (K855005) as substantially equivalent to a predicate device, with no explicit MRI safety or single-use designation. Storage requires protection from moisture and physical damage, adhering to standard construction material handling guidelines.
Questions
AI-generated answers, 1 Oct 2026
What is the Fiber Mesh designed to improve in cementitious materials like parge coats?
The Fiber Mesh is engineered to strengthen cementitious materials by embedding within the matrix, significantly enhancing structural integrity, durability, and resistance to mechanical stress and impact. This reduces cracking under load, making it ideal for applications where coatings must endure repeated stress or environmental exposure.
How is the Fiber Mesh supplied and what are its handling requirements?
The Fiber Mesh is supplied as a dry fiber reinforcement material, intended for direct integration into cement-based coatings such as parge coats. Since it is not sterile and classified as reusable for construction purposes, it must be stored in a dry environment, protected from moisture and physical damage, following standard construction material handling guidelines to maintain its effectiveness.
Is the Fiber Mesh intended for medical use or clinical applications?
No, the Fiber Mesh is not intended for medical or clinical use. It is classified under FDA product code DZE as a dental-related device for construction applications, specifically to reinforce cementitious materials like parge coats. Its use is limited to non-clinical, structural reinforcement in building materials.
What regulatory clearance does the Fiber Mesh hold, and what does this mean for its use?
The Fiber Mesh holds an FDA 510(k) clearance (K855005), determined to be substantially equivalent to a predicate device. This clearance confirms its safety and effectiveness for its intended use in reinforcing cementitious coatings, but it does not imply medical-grade sterility or suitability for clinical environments. The clearance is specific to its construction application under product code DZE.
Can the Fiber Mesh be reused, and what considerations should be taken for its longevity?
Yes, the Fiber Mesh is classified as reusable for construction applications. Its longevity depends on proper storage—protection from moisture and physical damage—and adherence to standard handling practices for construction materials. Since it is not sterile and designed for non-clinical use, reuse is limited to its intended structural reinforcement role in cementitious coatings.