# K964773: Dentemp One Step

- Pathway: 510(k) (Traditional)
- Applicant: Majestic Drug Co., Inc.
- Decided: Feb 21, 1997 after 86 days
- Product code: EMA (Cement, Dental)
- Device class: 2
- Regulation: 21 CFR 872.3275
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K982692: Sternomega Bonding Agent, Sternomega Composite LC, Sternomega Compomer LC (1998), 0 descendants of its own

## Recalls of this device
- Oct 4, 2023 · Class II · Z-0265-2024: Products were stored outside of labeled temperature requirements.
- Jun 23, 2022 · Class II · Z-1529-2022: Affected product was not appropriately stored in temperature-controlled areas between April 30, 2022 - June 10, 2022.

Source page: https://510kreport.com/device/K964773
Methodology: https://510kreport.com/methodology