# K192530: Surefil one Self-adhesive Composite Hybrid

- Pathway: 510(k) (Traditional)
- Applicant: Dentsply Sirona
- Decided: Jan 23, 2020 after 129 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
Longest line of descent: 5 generations back to K933139 (1994). 15 ancestors in all.
No later device cites it as a predicate yet.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K130223: Rmgi Fill, Pulpdent Corporation (2013) Summary page 4.
- K172382: GC Fuji Direct, GC America, Inc. (2018) Summary page 4.

## Indications for use
Class I to Class V restorations Core build up

Source page: https://510kreport.com/device/K192530
Methodology: https://510kreport.com/methodology