# K221909: J-Temp

- Pathway: 510(k) (Traditional)
- Applicant: Ultradent Products, Inc.
- Decided: Jul 1, 2022 after 1 day
- Product code: EBF (Material, Tooth Shade, Resin)
- Device class: 2
- Regulation: 21 CFR 872.3690
- 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 K153493 (2016). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K153493: Clip Flow, Voco GmbH (2016) Summary page 5.

## Indications for use
•Temporary restorations •Splinting between implant copings for impressions to resist impression material distortion •To provide structure for isolation clamping and to act as a barrier for endodontic irrigants •Bite ramps and temporary occlusal buildups during orthodontics

Source page: https://510kreport.com/device/K221909
Methodology: https://510kreport.com/methodology