# K991564: Jeltemp

- Pathway: 510(k) (Traditional)
- Applicant: J.F. Jelenko & Co., Inc.
- Decided: Jun 23, 1999 after 49 days
- Product code: EBG (Crown And Bridge, Temporary, Resin)
- Device class: 2
- Regulation: 21 CFR 872.3770
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device 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.

## Indications for use
JelTemp is for th: fabrication of long term temporaries using JelTemp Shell Teeth. The Dentist sends an impression of the prepared teeth to the lab. Models are powed from the impression, mounted and articulated. The technician preps models. JelTemp shell teeth are selected in the proper shade for the prepped abutments.

Source page: https://510kreport.com/device/K991564
Methodology: https://510kreport.com/methodology