# K972985: Splint IT

- Pathway: 510(k) (Traditional)
- Applicant: Jeneric/Pentron, Inc.
- Decided: Sep 24, 1997 after 44 days
- Product code: ELS (Splint, Endodontic Stabilizing)
- Device class: 2
- Regulation: 21 CFR 872.3890
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 2 cite it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K123823: Interlig (2013), 0 descendants of its own
- K122348: Quartz Splint System (UD, Woven, Rope, Mesh) Quartz Spint Resin QS Flow (2012), 0 descendants of its own

## Indications for use
Splinting periodontially involved and mobile teeth to prevent movement. To reinforce full denture and partial denture repairs. As a matrix between abutment teeth for receiving a temporary replacement tooth. As an aid in the reinforcement of temporary crowns and bridgework. As a space maintainer for orthodontically involved teeth.

Source page: https://510kreport.com/device/K972985
Methodology: https://510kreport.com/methodology