# K011159: One-Step Plus

- Pathway: 510(k) (Traditional)
- Applicant: Bisco, Inc.
- Decided: Jun 8, 2001 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
No predicates in its family tree.
5 later devices descend from it; 2 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

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

## Most influential descendants
- K081913: Metacem, Meta P&Bond, Metacem Silane Ceramic Primer (2008), 3 descendants of its own
- K171449: Metacem (2018), 1 descendant of its own
- K261166: Dia-Cem (2026), 0 descendants of its own
- K180802: Meta P&Bond (2018), 0 descendants of its own
- K093014: American Dental Products SE Bondeasy (2010), 0 descendants of its own

Source page: https://510kreport.com/device/K011159
Methodology: https://510kreport.com/methodology