Tescera Fiber Bundles, Fiber Mesh And Fiber Cylinders
FDA 510(k)Class II (US FDA 510(k))
by Bisco Inc.
Identifiers
- 510(k) Number
- K034024 FDA 510(k)
- FDA Product Code
- EBI FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 872.3760 FDA 510(k)
- Regulation Number
- 872.3760 FDA 510(k)
- Advisory Committee
- Dental FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Tescera Fiber Bundles, Fiber Mesh and Fiber Cylinders are dental devices composed of fiber-reinforced composite materials. They are intended for use in dental restorative procedures to reinforce and strengthen tooth structure.
These devices are supplied non-sterile and are intended for single-use dental applications. They are used chairside by dental professionals in accordance with standard dental practice and are regulated under FDA 510(k) clearance K034024.
Frequently asked questions
What are Tescera Fiber Bundles, Fiber Mesh and Fiber Cylinders used for?
They are used in dental restorative procedures to reinforce and strengthen tooth structure, providing support during chairside applications by dental professionals.
Are Tescera Fiber Bundles, Fiber Mesh and Fiber Cylinders sterile or non-sterile, and are they for single-use or reuse?
These devices are supplied non-sterile and are intended for single-use only, meaning they should be discarded after one patient application to prevent cross-contamination.
How are Tescera Fiber Bundles, Fiber Mesh and Fiber Cylinders supplied and used in a dental setting?
They are supplied non-sterile and used chairside by dental professionals during restorative procedures, following standard dental practice for placement and curing.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K034024 | Class II | Active |
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Manufacturer
- Manufacturer
- Bisco Inc.
- FDA Applicant
- Bisco, Inc.
Sources (1)
- FDA 510(k) K034024 24 fields · synced Sep 21, 2026