# K192022: DiaTemp Flow

- Pathway: 510(k) (Traditional)
- Applicant: DiaDent Group International
- Decided: Feb 13, 2020 after 199 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: 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 4.

## Indications for use
1. Temporary inlay and onlay treatments of the cavity. 2. Sealing of openings for implant screws. 3. Relining material for temporary crowns and bridges. 4. Covering of the gingival margin. 5. Fixing of resin matrix during filling placement.

Source page: https://510kreport.com/device/K192022
Methodology: https://510kreport.com/methodology