# K072713: Ion Dental Resin System

- Pathway: 510(k) (Traditional)
- Applicant: Dentsply International, Inc.
- Decided: Oct 12, 2007 after 17 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 K011560 (2001). 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)
- K032892: Modification to Trubyte Denture Base Resin System, Dentsply Intl. (2003) Summary page 1.

## Indications for use
ION Dental Resin System is indicated for the fabrication and/or repair of prescription therapeutic dental appliances (e.g. occlusal guards) used to mitigate damage associated with parafunctional dental habits (e.g. bruxism).

Source page: https://510kreport.com/device/K072713
Methodology: https://510kreport.com/methodology