# K031070: Carbon Fiber Bridge, Model 28757

- Pathway: 510(k) (Traditional)
- Applicant: Nobel Biocare AB
- Decided: Jul 3, 2003 after 90 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 K003333 (2001). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 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.
- K011788: Everstick, Stick Tech, Ltd. (2001)
- K003333: STICK, Stick Tech, Ltd. (2001) Summary page 1.

## Indications for use
The Carbon Fiber Bridge is indicated for use as a denture base material providing reinforcement of prosthetic reconstructions in the treatment of fully or partially edentulous patients in order to restore the patient’s chewing function.

Source page: https://510kreport.com/device/K031070
Methodology: https://510kreport.com/methodology