# K033309: Premier Implant Cement, Model 3001450

- Pathway: 510(k) (Traditional)
- Applicant: Premier Dental Products Co.
- Decided: Jan 26, 2004 after 104 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.
4 later devices descend from it; 3 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K134021: Estemp Implant, Estemp Clear (2014), 1 descendant of its own
- K262983: EsTemp Implant (2026), 0 descendants of its own
- K122549: Dento Temp (2013), 0 descendants of its own
- K101044: Retrieve Implant Cement (2010), 0 descendants of its own

## Indications for use
Premier Implant CementTM is a non-eugenol temporary cement for luting implant-retained crowns.

Source page: https://510kreport.com/device/K033309
Methodology: https://510kreport.com/methodology