# K051866: Premier Temporary Cement

- Pathway: 510(k) (Traditional)
- Applicant: Premier Dental Products Co.
- Decided: Sep 6, 2005 after 57 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.
8 later devices descend from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K100752: Peak Universal Bond (Light Cure Resin Adhesive and Chlorhexidine) (2010), 7 descendants of its own
- K161051: All-Bond Universal w/BAC (not finalized) (2016), 6 descendants of its own
- K230465: Hi-Bond Universal (2023), 2 descendants of its own
- K240743: Peak Universal Bond (2024), 1 descendant of its own
- K213401: DIAPLUS Universal (2022), 1 descendant of its own

## Indications for use
Premier Temporary Cement is recommended for the cementation of temporary crowns, bridges, inlays and onlays.

Source page: https://510kreport.com/device/K051866
Methodology: https://510kreport.com/methodology