# K061735: Infibra, Model 1200

- Pathway: 510(k) (Traditional)
- Applicant: Global Dental Products, Inc.
- Decided: Sep 8, 2006 after 80 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: 1 generation 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)
- K913040: Ribbond (TM), Ribbond, Inc. (1991) Summary page 1.
- K000346: EZ Connect, Kerr Dental Materials Center (2000) Summary page 1.

## Indications for use
Infibra is intended for use by dentists to provide reinforcement to acrylic or composite resins used for dental restorations. It can be used for the following applications: As reinforcement in manufacturing and/or repairing full or partial dentures as well as overdentures. night-guards and orthodontic appliances. To repair and reinforce resin or composite prostheses including temporary and permanent bonded and removable bridges- To reinforce splints used to immobilize teeth.

Source page: https://510kreport.com/device/K061735
Methodology: https://510kreport.com/methodology