# K252165: Zirconomer P

- Pathway: 510(k) (Traditional)
- Applicant: Shofu Dental Corporation
- Decided: Oct 28, 2025 after 110 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.
No later device cites it as a predicate yet.
0 of 1 device 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.

## Indications for use
Class I and II restorations in deciduous teeth Class I, and non-stress bearing Class II restorations in permanent teeth Stress bearing Class II restorations in permanent teeth , keeping ≥1 mm distance from the cusp tips

Source page: https://510kreport.com/device/K252165
Methodology: https://510kreport.com/methodology