# K050426: Temposil, Model 6720

- Pathway: 510(k) (Traditional)
- Applicant: Coltene/Whaledent AG
- Decided: Mar 18, 2005 after 28 days
- Product code: EMA (Cement, Dental)
- Device class: 2
- Regulation: 21 CFR 872.3275
- 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
- temporary cementing of temporary crowns and bridges - temporary cementing of final restorations

Source page: https://510kreport.com/device/K050426
Methodology: https://510kreport.com/methodology