# K211237: UltraTemp Rez II

- Pathway: 510(k) (Traditional)
- Applicant: Ultradent Products, Inc.
- Decided: Jul 13, 2021 after 78 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: 2 generations back to K994261 (2000). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080768: Ultratemp Firm, Fast and Regular Set, Ultradent Products, Inc. (2008) Summary page 5.

## Most influential descendants
- K261937: PacTemp Automix NE (2026), 0 descendants of its own

## Indications for use
UltraTemp REZ II is indicated for temporization of provisional prosthesis or restorative procedures (i.e. provisional crowns, bridges, inlays, and on lays).

Source page: https://510kreport.com/device/K211237
Methodology: https://510kreport.com/methodology