# K984340: Sternomega Temporary Cement Automix NE, Model 220282/220281

- Pathway: 510(k) (Abbreviated)
- Applicant: Sterngold/Implamed
- Decided: Jan 8, 1999 after 35 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
Longest line of descent: 1 generation back to K970774 (1997). 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)
- K970774: Tempocem NE (Multiple), Foremost Dental Mfg., Inc. (1997) Summary page 1.

## Indications for use
SternOmega Temporary Cement Automix NE is indicated for use as a temporary cement for attaching all types of temporaries, e.g. temporary crowns, bridges, and inlays.

Source page: https://510kreport.com/device/K984340
Methodology: https://510kreport.com/methodology