# K053328: Biosplint Splinting Ribbon

- Pathway: 510(k) (Traditional)
- Applicant: Satelec
- Decided: Jan 25, 2006 after 55 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.
- K954689: Connect, Sybron Dental Specialties, Inc. (1995) Summary page 1.

## Indications for use
Stabilization of mobile teeth Temporary replacement of missing teeth Maintain of inter-dental spaces Reinforcement or repairing of temporary or permanent bridges

Source page: https://510kreport.com/device/K053328
Methodology: https://510kreport.com/methodology