# K192158: DiaTemp

- Pathway: 510(k) (Traditional)
- Applicant: DiaDent Group International
- Decided: Feb 13, 2020 after 188 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
Longest line of descent: 2 generations back to K934978 (1993). 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)
- K111666: Evadyne Temporary Crown and Bridge Resin, Neodental Chemical Products Co., Ltd. (2011) Summary page 4.

## Indications for use
All types of temporary fillings, temporary protection in inlay and onlay technique.

Source page: https://510kreport.com/device/K192158
Methodology: https://510kreport.com/methodology