# K034024: Tescera Fiber Bundles, Fiber Mesh and Fiber Cylinders

- Pathway: 510(k) (Traditional)
- Applicant: Bisco, Inc.
- Decided: Mar 19, 2004 after 81 days
- Product code: EBI (Resin, Denture, Relining, Repairing, Rebasing)
- Device class: 2
- Regulation: 21 CFR 872.3760
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K913040 (1991). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013881: Ribbond - Triaxial, Ribbond, Inc. (2002) Summary page 1.

## Indications for use
As reinforcement for: 1. Removable dentures 2. Crown and bridge (Composite) a. single units b. multiple unit bridges c. inlay bridges d. Maryland Bridges 3. Provisional Crown and Bridge a. single units b. inlay bridges c. multiple unit bridges d. Maryland Bridges 4. Splint device reinforcement (Bruxism Appliance) 5. Splinting of teeth 6. Orthodontic Appliances

Source page: https://510kreport.com/device/K034024
Methodology: https://510kreport.com/methodology