# K261937: PacTemp Automix NE

- Pathway: 510(k) (Traditional)
- Applicant: The Belport Company Inc., DBA Gingi-Pak
- Decided: Aug 7, 2026 after 58 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: 3 generations back to K994261 (2000). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K211237: UltraTemp Rez II, Ultradent Products, Inc. (2021) Summary page 5.

## Indications for use
PacTemp Automix NE is indicated for temporization of provisional prostheses or restorative procedures, including provisional crowns, bridges, inlays, and onlays.

Source page: https://510kreport.com/device/K261937
Methodology: https://510kreport.com/methodology